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Strategic Programs

Click on an orange Strategic Program box below to see all solutions by strategic program.

Drug Safety

Harmonize Process

Enable the industry to move toward greater harmonization of process to enable the industry to capture, optimize and experience efficiencies.

Patient Experience

Improve the patient experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.

Share Information

Enable the industry to facilitate the necessary and required sharing of information amongst industry stakeholders.

Site Experience

Improve the site experience by decreasing burden, so HCPs, sites and investigative staff are fully supported by trial sponsors, researchers have access to the data they need to improve study design, and medications are developed faster for patients in need.

Sponsor Efficiencies

Browse our solutions to overcome inefficiencies in research and development below. The majority of our solutions are free and publicly available. TransCelerate’s mission is to improve clinical research and development so that new medicines can be developed and delivered to patients faster.

Click a trial phase to learn more about the initiatives that help support stakeholders during that step of the journey

Drug Development Journey

DataCelerate®

DataCelerate®

A global technology platform that allows for multiple de-identified research and development data types to be voluntarily submitted, uploaded, converted, harmonized, and downloaded through an access-controlled, secured environment. Serving as a data lake solution, the robust development and scalable design of DataCelerate features a flexible single sign-on platform with an automated user interface to quickly develop translational insights across the research and development (R&D) continuum.

SEND Implementation for Cross-Study Analysis

Leveraging the Value of CDISC SEND Datasets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals (Paper)

A peer-reviewed paper which highlights the potential of SEND datasets for cross-study analysis and proposes solutions to address the challenges of doing so currently.

Common Templates for Nonclinical Studies

Nonclinical Common Report Template

A nonclinical report template as a companion to the currently available V1.0 Nonclinical Common Protocol Template for the purpose of supporting consistency and efficiencies in the report generation process and reduce the burden on sites, CROs, and sponsors.

Protocol Template for Repeat-Dose Toxicology Studies

With input from key stakeholders, BioCelerate developed a toxicology study protocol template meant for first-in-human enabling, 28-day repeat dose studies. The purpose of a common template is to facilitate efficiencies for CROs, sponsors and others involved in toxicology study execution or review. Includes a suite of tools to aid in adoption.

SEND Harmonization & Cross-Study Analysis: A Proposal to Better Harvest the Value from SEND Data (Paper)

Identifies common variability in certain SEND domains and to describe how variability can be managed to enable valuable cross-study analysis use cases. Also includes a webinar and overview on the implementation and use of CDISC SEND data packages with the aim of facilitating study analysis.

Toxicology Data Sharing: Leveraging Data Sharing to Enable Better Decision Making in Research and Development (Paper)

Facilitates understanding of Toxicology Data Sharing and the development process.

Toxicology Data Sharing/DataCelerate Use Cases

Examples of utilizing the DataCelerate platform to enable sharing, searching, viewing and downloading nonclinical toxicology and background control data across BioCelerate Member Companies.

Quality Management System

A Knowledge Management Framework and Approach for Clinical Development (Paper)

Describes a framework for effective knowledge management within clinical development. Includes a suite of change management tools.

Clinical Data Transparency

A Model Approach and De-Identification and Anonymization of Individual Patient Data in Clinical Studies (Paper)

Provides guidance and model approaches for redacting privacy information found in clinical study reports, anonymizing patient level data shared with the broader healthcare community and preparing and distributing layperson summaries to the general public and study participants. Now maintained by PHUSE.

eSource

Accelerating the Adoption of eSource in Clinical Research: A TransCelerate Point of View (Paper)

Provides a detailed assessment of the current state in the industry and opportunities to increase eSource adoption through four essential modalities.

Privacy Methodology for Data Sharing

An Overview of A Privacy Framework for Clinical Data Reuse Video

A video on the key aspects of TransCelerate's GDPR data reuse framework, including principles for reuse of clinical data, a glossary, use cases, and a best practice process.

Real World Data

Assuring Audit & Inspection Readiness-Consideration for the Use of RWD & RWE in Regulatory Decision-Making

This list of key considerations for RWD quality has been developed to assist researchers interested in using RWD for regulatory decision-making. Its purpose is to provide greater clarity as to the type of information and documentation regulators may request from data providers and sponsors of research about the sources and process by which RWD/RWE is compiled to inform a regulatory decision.

Privacy Methodology for Data Sharing

Clinical Data Sharing: A Proposed Methodology to Enable Data Privacy While Improving Secondary Use

This proposed methodology addresses issues related to privacy regulations and compliance in connection with secondary reuse of clinical trial data.

Clinical Content & Reuse

Clinical Template Suite Implementation Support Resource (ISR)

Master slide deck combining 21 legacy assets to support the implementation of the CTS within an organization.

Clinical Content & Reuse

Clinical Template Suite Implementation Toolkit

A set of tools to enable assessment and adoption of the Clinical Template Suite.

Modernizing Clinical Trial Conduct

Clinical Trials in 2031 and Beyond

Report that utilizes a scenario planning exercise to explore the potential drivers influencing the future of clinical trials. Includes four potential future scenarios of clinical trials and outlined the characteristics of each scenario.

Clinical Content & Reuse

Common Clinical Study Report (CSR) – Basic Word Edition

Document template with common structure and proposed model content, aligned with ICH E3 and CORE. Integrates with CPT and SAP templates.

Clinical Content & Reuse

Common Protocol Template (CPT) – Basic Word Edition

Document template with a harmonized and streamlined approach to the format and content of clinical trial protocols. Includes common structure, proposed model content and participant and TA libraries.

Common Serious Adverse Events (SAE) Fields

Common Serious Adverse Event Fields Overview & Outputs

A set of slides detailing the initiative’s background, its methodology for creating a core list of Common SAE Fields, and overview of the initiative’s outputs.

Clinical Content & Reuse

Common Statistical Analysis Plan (SAP) – Basic Word Edition

Document template with common structure and proposed model content, aligned with ICH E9. Integrates with CPT and CSR templates.

Comparator Network

Comparator Network

Web-based ordering system to execute comparator product transactions. Must be a Member of TransCelerate BioPharma.

Clinical Content & Reuse

CSR Considerations for Studies Disrupted by the COVID-19 Pandemic

Identified the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports to disruptions caused by COVID-19.

eSource

Data Mapping (FHIR-SDTM) for Labs, AEs, and SOA

Mapping of data elements between the HL7 FHIR standard and CDISC SDTM standard for labs, AEs, and SOA to enable interoperability between clinical data standards and healthcare data standards. Output was provided to HL7 to put through public comment.

Risk Based Monitoring

Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Parts 1 & 2 (Papers)

These papers provide a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. Describes the initial implementation steps designed to learn what organizational capabilities are necessary.

Risk Based Monitoring

Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations (Paper)

Focuses on detecting data quality issues, irrespective of origin or motive.

Digital Data Flow

Digital Data Flow Common Protocol Template-Common Line Interface Tool

A proof-of-concept utility tool to show how CDISC's Unified Study Definitions Model (USDM) can be mapped to the TransCelerate CPT format, and additionally demonstrate the automated population of an eCPT Word document by loading a USDM file directly from the SDR.    

Digital Data Flow

Digital Data Flow Communications Materials

Materials (DDF Overview, FAQs, CDISC Unified Study Definitions Model, GitHub page, and “What is Digital Data Flow?” video) to provide relevant stakeholders with a clear understanding of DDF's value proposition.

Digital Data Flow

Digital Data Flow Sponsor Company Transformation Tools

Set of communications materials, change management journey, organizational assessment, and key personas that can help enable digital data flow within sponsor organizations.

Digital Data Flow

Digital Data Flow Technology Architecture Scenarios Tool

A set of possible scenarios for the technical implementation of the Unified Study Definitions Model, provided to help companies think about how they might use the USDM and DDF concepts to better enable end-to-end data flow. 

eSource

eSource Informatics Continuum

The objective of the eSource Informatics Continuum is to help study sites determine their readiness for eSource implementation, by identifying their location on the continuum and pathway to increase interoperability. The continuum includes a diagram that shows different varying degrees of interoperability based on clinical informatics, starting with ‘traditional’ data collection, i.e., using paper medical records and paper case report forms (CRFs), and ending with ‘innovative’ data collection, which includes full interoperability and integration between clinical care and clinical research.

eSource

eSource Site Capability Questionnaire

Used by sponsors to help capture the site’s use of technology during the site qualification process. Intent is to facilitate the reduction of any administrative burden on sites by collecting information in a consistent manner.

Clinical Content & Reuse

eTemplates (eCPT, eCSR, eSAP)

The eTemplates are Word templates with technical functions to enable automation and clinical content re-use to downstream documents, processes, and registries.

Risk Based Monitoring

Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (Paper)

Assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of major and critical findings from TransCelerate member company internal audits.

Clinical Content & Reuse

Examining Possibilities for a Consistent Procedures Library to Modernize Clinical Trials: A TransCelerate Point of View

In 2021, the CC&R Team conducted a proof of concept exercise & landscape analysis to determine the general feasibility of establishing a procedures library to support protocol design and digitization. The results of that exercise, aimed at supporting the evolution toward a digitized protocol have been summarized in a whitepaper.

Diversity of Participants in Clinical Trials

FDA Diversity Plan Early Insights & Considerations

Provides an aggregated collection of insights and considerations gathered from Member Company interviews that help to inform operational strategies and identify how practical implementation of U.S. Food and Drug Administration (FDA) Diversity Plans may progress as industry thinking matures in this area. 

Site Qualification and Training

Forms for Investigator Sites

A series of harmonized forms and templates leveraged across sponsors and used by investigator sites for critical clinical trial activities.

Interpretation of Pharmacovigilance Guidances & Regulations

Global Pharmacovigilance Regulations: Call for Re-Harmonization Letter to the Editor of Journal of Clinical Trials (Paper)

A letter to the editor of Clinical Trials, noting a trend towards divergence of pharmacovigilance regulations. This letter is a call for re-harmonization to raise awareness of the issue and call for all stakeholders, in particular Health Authorities, to take efforts to re-harmonize.

Site Qualification and Training

Good Clinical Practice Training Mutual Recognition Program

GCP Training Providers can self-attest to meeting minimum criteria based on ICH GCP guidelines which facilitates reduction in duplicative training for Investigator Sites by allowing potential mutual recognition across sponsor companies.

Historical Trial Data Sharing

Historical Trial Data Sharing (Controls) DataCelerate®

Placebo/Standard of Care's new data home that will enable better searching and visualization of data shared among participating Member Companies.

Interpretation of Clinical Guidances & Regulations

ICH E8 Case Studies

A collection of three sponsor company case studies to demonstrate ICH E8 (R1) concepts in action.

Interpretation of Clinical Guidances & Regulations

ICH E8 Culture & Engagement Resource Pack

A compilation of links to resources intended to provide informational and educational materials for the clinical development ecosystem to support the understanding, implementation, and operationalization of these newly introduced concepts in ICH E8 (R1).​

Interpretation of Clinical Guidances & Regulations

ICH E8 Landscape Assessment

The Landscape Assessment benchmarks information gathered from a survey of sponsor companies to help understand the progress and challenges of ICH E8 (R1) implementation.

Interpretation of Clinical Guidances & Regulations

ICH E8: Resources for the Application of Critical to Quality Factors

Considerations and information to help with the interpretation and application of Critical to Quality Factors throughout clinical studies. ​

Interpretation of Clinical Guidances & Regulations

ICH E8: Stakeholder Engagement for Clinical Development

A tool to help study sponsors manage quality by facilitating the implementation of ICH E8’s principles regarding stakeholder engagement throughout the clinical development lifecycle.

Site Qualification and Training

Informational Programs for Investigator Sites

A series of videos that describe the basic components of clinical research in accordance with the ICH Good Clinical Practice. Now owned by SCRS.

Risk Based Monitoring

Integrated Quality and Risk Management Plan Framework

The IQRMP provides a tailored and integrated plan for a clinical trial that will include the clinical and medical risks identified at the program leveland assists in shared responsibility across all functions involved in collecting, analyzing and reporting clinical trial data.

Investigator Registry

Investigator Registry

Alongside the Shared Investigator Platform, a combined solution providing accelerated identification of qualified investigators, facilitates site/sponsor interactions, and reduces administrative burden of clinical trial operations.

eSource

Issues Related to Non-CRF Data Practices (Paper)

Practices and procedures for the collection and retention of non-CRF data are crucial to maintaining data accuracy and integrity. To guide the development of such practices and procedures, this paper outlines certain high-level best practices related to handling and managing non-CRF data.​

Interpretation of Clinical Guidances & Regulations

Key Risk Management Changes in Good Clinical Practice [ICH E6(R3)] Infographic

An infographic that highlights key changes to the risk management elements within Good Clinical Practice Version 2 and 3. Co-developed with ACRO, this infographic aims to allow industry to easily identify the impact to their process and how to react for efficient ICH E6 (R3) implementation.

Risk Based Monitoring

Measuring the Impact of Risk Based Monitoring (Paper)

Provides an overview of the TransCelerate RBM initiative’s original vision for specific metrics with the potential to effectively measure the value and impact of RBM from multiple perspectives and an analysis of how those original, suggested metrics have been put into realworld practice.

Historical Trial Data Sharing

Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities (Paper)

As part of the continuing dialogue with Regulators, this paper aims to address the data selection methodology challenges, particularly when Placebo/Standard of Care is used to augment or substitute clinical control arms.

Modernization of Statistical Analytics

Modernization of Statistical Analytics (MSA) Framework

This Framework is based upon a methodology that establishes the principles of accuracy, reproducibility, and traceability for a modern analytical software environment to demonstrate that the results it generates is reliable. A set of best practices and guiding principles is also provided to support the Framework’s implementation across industry sponsors and other stakeholders. Additional resources include an infographic and a case for adoption.

Modernizing Clinical Trial Conduct

Modernizing Clinical Trial Conduct Process Frameworks

Outlines various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected modern solutions.

Modernizing Clinical Trial Conduct

Operational Complexity Assessment Tool

An interactive tool that assesses the complexity or lack of complexity of implementing selected modern solutions in a clinical trial, based on several trial aspects that could potentially impact the circumstances of implementation.

eSource

Optimizing the Use of Electronic Data Sources in Clinical Trials, The Landscape, Parts 1 & 2 (Papers)

These landscape assessments provide insight into sponsor company eSource activities and the environment affecting eSource adoption based on input from TransCelerate Member Companies, standards organizations, and regulatory authorities.

Patient Experience

Personalized Clinical Trials Framework

The interactive Personalized Clinical Trials Framework is a set of practical considerations to support the R&D ecosystem (i.e., sponsors, sites, third parties, and other clinical trial stakeholders) with understanding and evaluating options that enable a more personalized experience for clinical trial participants across diverse populations. The framework provides fourteen potential opportunities to enable personal choice into a clinical trial, and includes considerations to help action the opportunity, potential value and benefits, as well as tools and resources to support implementation.

Historical Trial Data Sharing

Placebo/Standard of Care Adoption & Implementation Toolkit

A toolkit that describes lessons learned and best practices that can be adopted by participating Member Companies.

Real World Data

Preparing to Engage with Health Authorities on Real World Evidence for Medicines Infographic

Provides a visual overview of the Health Authority Engagement Considerations including key methodologies, Health Authority interactions, and illustrative Case Studies for a broader understanding of the Preparing to Engage with Health Authorities on Real World Evidence for Medicine paper.

Real World Data

Preparing to Engage with Health Authorities on Real World Evidence for Medicines: A TransCelerate Perspective

Provides various options for Sponsors to consider on when to engage with Health Authorities, the type of input, and decisions needed to come to a mutually transparent path forward to include RWE in regulatory decision-making for defined use cases.

Quality Management System

Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development (Paper)

Describes a framework for effective processes management within clinical development. Assists organizations in understanding the benefits and basic components of process management for clinical development. Includes a suite of change management tools.

Protocol Deviations

Protocol Deviations Assessment Plan

A template to assist in the identification and documentation of protocol-specific "important" deviations.

Protocol Deviations

Protocol Deviations Map

A map of the protocol deviation management process containing processes for both important and non-important deviations.

Protocol Deviations

Protocol Deviations Overview Video

A video that explains TransCelerate's Protocol Deviations Toolkit and explains potential use scenarios and other examples where the tools can be applied.

Protocol Deviations

Protocol Deviations Process Guide

A proposed framework describing flexible protocol deviations management approaches, elements for consideration based upon proposed interpretation of the ICH E3 definition for important protocol deviations and other associated PD Guidance with links to the PD Process Map.

Protocol Deviations

Protocol Deviations: A Holistic Approach from Defining to Reporting (Paper)

This manuscript, published in a peer-reviewed journal, highlights the contents​ of the Protocol Deviation toolkit. 

Quality Management System

Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development (Paper)

Describes a framework for effective risk management within clinical development. Assists organizations in understanding the benefits and basic components of risk management in clinical development. Includes a suite of change management tools.

Interpretation of Clinical Guidances & Regulations

Quality Tolerance Limits Framework & Webinar

A framework including a proposed definition of the term ‘QTL’ , process maps/steps and examples of QTL parameters. The "Demystifiing Quality Tolerance Limits" webinar reviews guidance and considerations for QTL implementation in clinical development.

Interpretation of Clinical Guidances & Regulations

Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development

A peer-reviewed publication sharing the work done on the definition of the term ‘QTL’ and parameter guides.

Risk Based Monitoring

RBM Interactive Guide

A multi-chapter, interactive guide to all risk-based monitoring components.

Risk Based Monitoring

Risk-Based Monitoring Data Quality Management

"Implementation considerations for establishing quality tolerance limits (QTLs) and risk reporting in the clinical study report (CSR) are examined and described. This framework aims to be consistent with ICH E6 (R2) and TransCelerate papers on Risk Based Monitoring (RBM) and Quality Management System (QMS)."

Risk Based Monitoring

Risk-Based Monitoring Metrics Solutions/Change Tools

These tools delve deeper into the metrics for measuring RBM impact.

Risk Based Monitoring

Risk-Based Monitoring Risk Assessment and Categorization Tool (RACT) & Tools

A model approach to apply Risk-Based Monitoring, to direct monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality. Supported by a suite of tools to facilitate implementation, including a library of >100 risk indicators which sponsors may choose to apply in their clinical trials.

Risk Based Monitoring

Risk-Based Monitoring Technology Considerations (Papers)

Two papers hat delve deeper into the technology considerations of RBM.

Shared Investigator Platform

Shared Investigator Platform

Alongside the Investigator Registry, a combined solution providing accelerated identification of qualified investigators, facilitates site/sponsor interactions, and reduces administrative burden of clinical trial operations. Now owned and maintained by Cognizant.

Historical Trial Data Sharing

Sharing Historical Trial Data to Accelerate Clinical Development (Paper)

A paper on sharing historical trial data to accelerate clinical development which highlights TransCelerate's Placebo/Standard of Care data sharing and DataCelerate.

Risk Based Monitoring

Site Level Risk Assessment Considerations

Provides examples to help demonstrate possible alternatives for quantifying initial and ongoing site level risk.

Risk Based Monitoring

Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct (Paper)

Explores a a cross-functional, collaborative approach to statistical monitoring that can adapt to study design and data source and use a combination of statistical screening techniques and confirmatory graphics.

Digital Data Flow

Study Definitions Repository Reference Implementation & Associated Source Code

A functioning, example approach showing how the Unified Study Definitions Model can be represented as a novel central component to connect systems that produce protocol information with those that consume it to drive study operations.  

eSource

Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective (Paper)

Provides insights into the technological complexities, operational scope, and the actions required from pharmaceutical industry stakeholders to adopt the eSource framework for clinical research at scale.

Risk Based Monitoring

Technology Considerations to Enable the Risk-Based Monitoring Methodology (Paper)

Lays out the high-level considerations when designing and building an integrated technology solution that will aid in scaling the methodology across an organization’s portfolio.

Interpretation of Clinical Guidances & Regulations

The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8

The aim of this paper is to enhance the understanding of specific topics detailed in ICH E8 including QbD, CtQ, Fit for Purpose, and Stakeholder Engagement.  

Quality Management System

TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework (Paper)

Identifies methods for operationalizing in integrated QMS through which sponsors can systematically plan, control quality, monitor and improve performance in complex clinical research environments. Includes a suite of change management tools.

Quality Management System

TransCelerate’s Clinical Quality Management System: Issue Management (Paper)

Describes a framework for effective issue management within clinical development. Includes a suite of change management tools.

Digital Data Flow

Unified Study Definitions Model

Developed with CDISC, USDM provides the standard data model, controlled terminology and APIs needed to specify and share a protocol design in a digital format. USDM v2.0 includes the addition of biomedical concepts and complex time points into the model. 

Interpretation of Clinical Guidances & Regulations

What You Need to Know about ICH E8 Infographic

An easily sharable and digestible document for introducing and interpreting key components of ICH E8 such as Critical to Quality Factors, Open Dialogue, Critical Thinking, and Fit for Purpose. ​

Intelligent Automation Opportunities in Pharmacovigilance

2020 Technology Matrix

Provides information regarding the types of technologies available in pharmacovigilance and maps the level of implementation of each technology to the Individual Case Safety Report (ICSR) process.

Rapid Signal Assessment Using Real World Data

A Framework for Rapid Signal Assessment Using Real-World Data

Provides an end-to-end high-level process map on using RWD as an option to more rapidly conduct safety signal assessments. It includes a series of elements/components designed to additionally help stakeholders have a common understanding and communication of concepts and processes for RSA RWD.   

Interpretation of Pharmacovigilance Guidances & Regulations

A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle & Overview Video

A Framework including a comparison of requirements for presentation of risks across the guidelines and phases of the product lifecycle, along with operational considerations on how to present risks in key regulatory/safety documents. Accompanying this framework is an overview video that covers key aspects of the framework.

Intelligent Automation Opportunities in Pharmacovigilance

Artificial Intelligence-Based Validation Case Study Themes

Provides themes and considerations from use cases focused on early adopters' experiences applying AI to pharmacovigilance applications.

Intelligent Automation Opportunities in Pharmacovigilance

Automation Opportunities in Pharmacovigilance: An Industry Survey (Paper)

This paper highlights opportunities and provides an initial starting point for companies considering ICSR process automation. Supplemented by the Interactive ICSR & Automation Technologies Tool (IATT).

Intelligent Automation Opportunities in Pharmacovigilance

Black Swan Events and Intelligent Automation for Routine Safety Surveillance

This published paper discusses black swan events in the context of pharmacovigilance and the role of machine learning in helping to mitigate such events. The paper explores effective approaches to managing risk of potential black swan events and outlines several strategies to address those risks of potential black swan events during data ingestion. Here is a video discussing the paper in detail.

Interpretation of Pharmacovigilance Guidances & Regulations

Call to Action: Harmonization of Pharmacovigilance Regulations for Post-Marketing Pregnancy and Breastfeeding Safety Studies Paper

The article focuses on post-marketing pregnancy and breastfeeding safety studies, raising awareness of the industry perspective on challenges due to the lack of harmonization and gaps in current PV regulations. It is intended to increase awareness among the industry and health authorities and calls for global legislation harmonization.

Interpretation of Pharmacovigilance Guidances & Regulations

Digital Health Glossary

A compilation of definitions provided by regulators, industry consortia, and other stakeholders for common vocabulary and synonyms, which will aid in understanding terms directly related to digital health to increase clarity, communication, and better decision-making.

Interpretation of Pharmacovigilance Guidances & Regulations

Digital Health Reference Resource Library

A catalog of identified regulations and guidelines to aid in understanding what is driving digital health in selected countries.

Interpretation of Pharmacovigilance Guidances & Regulations

FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide & Webinar

An Implementation Guide to aide pharmaceutical manufacturers‘ understanding of ambiguous areas of the PMSR for Combination Products Draft Guidance for Industry and FDA Staff. In addition, a webinar presentation is included where TransCelerate team members provide an overview of the FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide.

Value of Safety Information Data Sources

Identifying the Value of Information Data Sources to Improve Patient Safety Infographic

This infographic overviews the main study findings and data from two papers published by TransCelerate’s VSIDS’s team.

Intelligent Automation Opportunities in Pharmacovigilance

Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks

This Drug Safety article reports on an analysis that quantifies the amount of Individual Case Safety Report (ICSR) replication within the pharmacovigilance ecosystem. It is the first quantification of the phenomenon of ICSR replication across Health Authority and marketing authorization holder safety databases.

Value of Safety Information Data Sources

Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient Safety (Paper)

Provides perspectives regarding hierarchy of value for collecting, processing, analyzing and reporting of adverse event information.

Intelligent Automation Opportunities in Pharmacovigilance

Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance

This published paper is a follow-up to a previous Individual Case Study Report paper which combines data from 2019-2021​. The paper describes major trends​, interprets and suggests why these trends exist​, includes an updated ICSR Heat Map​, and includes an update for case studies from the Foundation Paper Table 2. Here is a video discussing the paper in detail.

Intelligent Automation Opportunities in Pharmacovigilance

Interactive ICSR & Automation Technologies Tool (IATT)

An interactive tool that highlights opportunities and benefits for automation in the ICSR process and provides a visual representation of those opportunities.

Pharmacovigilance Agreements Optimization

Marketing Partner Audit Conduct

Offers options and considerations on different audit approaches which can help generate efficiency in the marketing partner audit program.   

Pharmacovigilance Agreements Optimization

Marketing Partner Audit Responses & Follow-Up

Provides some points to consider before starting audit response development. The tools deal with the end of the audit lifecycle, specifically the audit response process and CAPA follow up. 

Pharmacovigilance Agreements Optimization

Marketing Partner Audit Risk Prioritization

This document outlines considerations for a risk-based approach to prioritizing and scheduling Marketing Partner audits. 

Pharmacovigilance Agreements Optimization

Marketing Partner Audit Risk Prioritization Scorecard

An example scorecard to help companies develop a risk-based score derived from company-selected and analyzed criteria. 

Pharmacovigilance Agreements Optimization

Marketing Partner Audit Scheduling & Scoping

Provides some points to consider when scheduling and scoping business partner audits. Note that this solution deals with the preparation phase of the audit lifecycle and helps design the appropriate scope for pharmacovigilance audits. 

Pharmacovigilance Agreements Optimization

Negotiating Your Way through the Vigilance Agreement Maze-Is There a Better Way? Paper

A peer-reviewed paper published in Therapeutic Innovation & Regulatory Science (TIRS). The article can be leveraged to find simplification and efficiencies to optimize the process of developing contractual agreements for pharmacovigilance.

Pharmacovigilance Agreements Optimization

Pharmacovigilance Agreements Glossary

A listing of key definitions and synonyms often incorporated into Pharmacovigilance Agreements.

Pharmacovigilance Agreements Optimization

Pharmacovigilance Agreements Optimization Interactive Process Map

The Process Map solution illustrates the end-to-end PVA lifecycle and offers key considerations throughout the development and maintenance of PVAs. In addition, there are several sets of tools available to address key bottleneck areas within the lifecycle, e.g., negotiation.

Pharmacovigilance Agreements Optimization

Pharmacovigilance Agreements Optimization Table of Contents

A framework of modules, headings, points to consider, and regulatory references in relation to pharmacovigilance exchange of information and obligations between parties. This TOC was developed in the context of sponsor to sponsor, marketing authorization holder (MAH) to MAH, or sponsor to MAH and vice versa negotiations.  Supplemental Materials were published in July 2023.

Pharmacovigilance Agreements Optimization

Pharmacovigilance Agreements-Negotiating Safety Data Exchange Timelines: To Agree or Disagree? That Is the Question

This peer-reviewed article is potentially the first benchmarking survey of contracts covering safety data exchange conducted within the pharmaceutical industry (the survey was issued to TransCelerate Member Companies). Data were analyzed to determine the most common types of safety data exchanged, and the associated data exchange timelines, providing information from 378 individual contracts which included data from clinical trials and from post marketing sources.

Pharmacovigilance Agreements Optimization

Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That Is The Question Paper

A peer-reviewed paper published in Therapeutic Innovation & Regulatory Science. This paper is potentially the first benchmarking survey of contracts covering safety data exchange conducted within the pharmaceutical industry (the survey was issued to TransCelerate Member Companies). Data were analyzed to determine the most common types of safety data exchanged, and the associated data exchange timelines. These data may provide an opportunity for companies to assess how their own timelines compare with others, and to consider whether there are actions they may take that could potentially improve negotiation and procedural efficiency.

Interpretation of Pharmacovigilance Guidances & Regulations

Points to Consider Concerning the Use of Medicines in Pregnancy throughout the Product Lifecycle

Provides considerations, based on global regulatory requirements, when including
pregnant women in clinical trials through post-marketing studies and is aimed at
raising awareness of current regulatory requirements, industry perspective on
challenges, and considerations when developing medicinal products to be used for
maternal health.

Interpretation of Pharmacovigilance Guidances & Regulations

Pregnancy & Breastfeeding Initiatives & Regulatory Landscape Assessment

This Landscape Assessment summarizes the current regulatory ecosystem (and relevant initiatives) in selected territories, covering drug safety regulations and guidances addressing pregnancy and breastfeeding from early clinical development to post-marketing settings. 

Interpretation of Pharmacovigilance Guidances & Regulations

Pregnancy & Breastfeeding Regulatory Landscape Comparison by Regulation Topic

Comparison of in-scope guidances and regulations in the selected territories, against ICH and CIOMS pregnancy and breastfeeding provisions.

Rapid Signal Assessment Using Real World Data

Rapid Real-World Data Analysis Plan for Signal Assessment Template

The Alternative to a Full Protocol offers a potential alternative to a full study protocol for use in the RSA process, which is described in the RSA RWD Framework. It is a generic template for rapid non- or less-complex RWD analysis types, which typically would not require a full study and protocol, along with guidance for its usage. 

Intelligent Automation Opportunities in Pharmacovigilance

Signal Management-Intelligent Automation Opportunities for Signal Detection

Identifies how a representative sampling of major pharmaceutical companies are currently using intelligent automation for various PV process steps within a generic signal management framework and thereby raises awareness as to the potential opportunities for the broader industry in this area. 

Interpretation of Pharmacovigilance Guidances & Regulations

The Evolving Remit of the Reference Safety Information: Observations on Implementation of the 2017 Clinical Trials Facilitation Group (CTFG) Question & Answer Document

This manuscript highlights industry challenges in operationalizing the requirements of the 2017 Clinical Trial Facilitation Group (CTFG) Question & Answer document. Surveys reveal actions taken in the creation, submission and implementation of the Reference Safety Information (RSI) to meet the requirements of the CTFG and EU national competent authorities whilst staying compliant with global regulatory requirements.

Intelligent Automation Opportunities in Pharmacovigilance

Understanding Case Reporting Transmission Networks in Drug Safety: The Impact of Replication Webinar

This webinar recording is a presentation and panel discussion on TransCelerate's Individual Case Study Report Replication paper, the first quantification of the phenomenon of ICSR replication across Health Authority and marketing authorization holder safety databases. The panel discusses the value of reducing the duplicative, replicated ICSR-related activities and the impact of that reduction on patient safety and prompting discussions about mitigating regulatory and technical approaches. The webinar can be watched at Understanding Case Reporting Transmission Networks in Drug Safety: The Impact of Replication - YouTube. Presentation slides can be accessed here.

Intelligent Automation Opportunities in Pharmacovigilance

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices (Paper)

This position paper provides considerations to the industry on validation strategies that can be utilized for emerging AI-based automation technologies. It is intended to facilitate dialogue and collaboration with Health Authorities and industry on this topic. 

Patient Journey

Clinical Research Awareness

Clinical Research Awareness: A Proposed Study Design to Assess the Role of Shared Decision Making in the Consideration of Clinical Trial Participation

This paper aims to enable researchers to assess the value and measures the impact of Shared Decision Making (SDM) on patient and HCP satisfaction.

Diversity of Participants in Clinical Trials

Diversity by Design: Proactive Approaches to Facilitate Industry-Wide Diversification of Clinical Trial Participants Webinar

Presentation slides can be viewed here. The webinar focuses on:

  • An overview of the importance of improving the representation of diverse patient populations in clinical trials
  • Key considerations to accelerate industry-wide diversification of clinical trial participants
  • Available tools to action the key considerations to prospectively evolve trial design, enrollment, and participation strategy
  • How to navigate the newly redesigned Diversity of Participants in Clinical Trials initiative website

Clinical Research Awareness

Exploring the Impact of Shared Decision Making in Clinical Trial Consideration Paper

This paper explores shared decision-making in patient-provider conversations with the aim to enable patients to better understand clinical trials as a care option.

Clinical Research Awareness

One Person Closer Campaign

The photojournalist campaign aims to show doctors, nurses and other HCPs that they can help facilitate research that advances science and that may benefit their patients. 

Clinical Research Access & Information Exchange

Clinical Trial Registration Tool

A tool individual clinical trial sponsors can use to proactively evaluate the quality of the clinical trial registration data they submit to government-owned registries. Download to take a closer look at to leverage the Clinical Trial Registration Tool.

Clinical Research Access & Information Exchange

Improving Investigator Site Contacts

Provides guidance on steps towards closing the gap between individuals willing to participate in clinical trials and the enrolling investigative sites for those trials, by making it easier to contact site locations through clinical trial registry listings.

Clinical Research Access & Information Exchange

Registry of the Future Wireframe

A proposal and wireframe mock-up, designed in conjunction with patients, illustrating patient-focused improvements for adoption to be incorporated into clinical trial registries to improve utility and access to clinical trial information.

Clinical Research Access & Information Exchange

What Patients Want to See in Clinical Trial Registries Infographic

The infographic, based on a global patient survey with 1,070 responses, details what information is helpful when patients begin their search for clinical trials in a registry, and what information patients would like to see in the brief title and brief summary.

Patient Technology

Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges (Paper)

This paper is a pharmaceutical industry perspective on opportunities and challenges with adoption and implementation of patient technology in clinical trials.

Diversity of Participants in Clinical Trials

Collaboration Hub Sponsor Toolkit: Portfolio and Program-Level Considerations for Diversity, Equity, and Inclusion of Participants in Clinical Trials (DEICT)

A toolkit designed to support sponsor efforts to leverage key portfolio and program/compound level diversity considerations to facilitate meaningful* inclusion of diverse patient populations in the drug development lifecycle. The inclusion of diverse patient populations in clinical trials is of increasing importance to health authorities including the US Food and Drug Administration and more inclusive trial practices are being strongly encouraged. To address this call to action, this toolkit includes guidance for sponsors across sponsors’ portfolios and compound development. 

* Integrated design and operational strategies that support the generation of robust actionable data for diverse patient populations

Patient Technology

Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations Paper

To advance industry use of Novel Digital Endpoints (NDEs) to support drug development, this paper outlines a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA).

Diversity of Participants in Clinical Trials

Diversification Practices

Guidance for sponsors and clinical trial sites regarding better practices and processes for minority recruitment.

Diversity of Participants in Clinical Trials

Diversity Community-Based Site
Engagement and Capacity Building

Provides an aggregated collection of insights and perspectives from the attending organizations of a June 9 Roundtable Event, regarding considerations that sponsors, sites, and others have taken to enhance engagement and capacity building for community-based sites.​

Diversity of Participants in Clinical Trials

Diversity of Participants in Clinical Trials Reference Table & Landscape of Available Solutions

Descriptions and links to publicly available resources for Patients, Sponsors, and Sites/HCPs. Also, includes a visual landscape of the resources described and linked in the reference tables. The landscape also indicates resources that serve overlapping stakeholder communities.

eConsent

eConsent Business Case

A customizable PowerPoint template available for Member Companies to support the creation of a business case for the implementation/adoption of eConsent.

eConsent

eConsent Implementation Guidance

Document outlining comprehensive, practical eConsent implementation approaches and considerations for sponsors and other interested parties. Developed through a collaboration with patients and sites, health authorities (HAs) and institutional review boards (IRBs)/independent ethics committees (IECs), and clinical research organizations (CROs).

eLabels

eLabels Concept Materials

Guidance on what factors to consider when designing a universal eLabel.

eLabels

eLabels Design and Delivery Toolkit

Implementation toolkit available on the TransCelerate external website providing guidance on voluntary implementation and to assist in Healthcare Authority engagements. Includes design, regulatory, technical and stakeholder considerations.

eLabels

eLabels Frequently Asked Questions

A document answering common questions around eLabels.

eLabels

eLabels Implementation Planning Tools

A series of guidance documents and planning tools to help support voluntary implementation planning for eLabels solutions.

eLabels

eLabels Technology Approach

Guidance on what factors to consider before implementing eLabels technology.

Patient Experience

Gratitude Toolkit Implementation Insights User Guide

 A set of deliverables that sponsors, with their site partners, can leverage to acknowledge and show appreciation to clinical trial participants. The GRAT streamlines options and tactics, providing a compilation of deliverables for study teams in healthcare for ease of implementation, with reduced friction and time.

Clinical Research Access & Information Exchange

Improving Investigative Site Contact Options on Clinical Trial Registries: Making It Easier for Patients to Find Clinical Trials (Paper)

Paper offers guidance on a practical first step toward closing the gap between individuals willing to participate in clinical trials and the enrolling investigative sites for those trials, by making it easier to contact site locations through clinical trial registry listings.

Participant Data Return

Individual Participant Data Return (iPDR) Package

Provides general considerations to enable data return to clinical study participants and includes three components – a Socialization Presentation, Considerations Guide, and Template. 

eConsent

Member Company eConsent Asset Value and Impact Case Study

Case study with empirical data to illustrate value and impact of eConsent assets for Member Companies, informed by aggregated Member company survey data regarding the usage and value of eConsent assets.

Modernizing Clinical Trial Conduct

Modernizing Clinical Trial Conduct Workshop Findings

TransCelerate and the Association for Clinical Research Organizations’ (ACRO) CRO Forum conducted a collaborative workshop to explore root cause challenges and enablers of success for the use of modern methodologies in clinical research; topics include telemedicine, direct to patient shipping, home health visits, and local lab usage.

Patient Experience

Offering Choice to Patients: An Overview of the Personalized Clinical Trials Framework Webinar

Feedback from clinical trial participants indicates they want options for their clinical trial experience. TransCelerate BioPharma's Personalized Clinical Trials Framework is a set of practical considerations to support the R&D ecosystem (i.e., sponsors, sites, third parties, and other clinical trial stakeholders) to offer options that enable a personalized experience for clinical trial participants across diverse populations. Slides for this webinar can be found here.

The webinar focuses on:

  • An overview of the Personalized Clinical Trials Framework, which was developed in partnership with patients, sites, and clinical research organizations
  • Insights into how to incorporate the Personalized Clinical Trials Framework as an integral part of clinical trials within your organization

Participant Data Return

Participant Data Return Resource Pack

A document that provides access to a consolidated set of resources from within the clinical research ecosystem that can assist with returning individual data globally.

Clinical Research Access & Information Exchange

Patient Communication Templates

Communication templates that sponsors may use, at their discretion, in order to facilitate exchanging information with clinical trial participants at the outset of clinical trial participation, during the trial and afterwards.

Patient Technology

Patient Considerations Toolkit

A set of considerations developed with input from patient discussions that when addressed (by sponsors) can result in improved patient experience using patient technology in clinical trials. 

Clinical Research Access & Information Exchange

Patient Preferences When Searching for Clinical Trials and Adherence of Study Records to ClinicalTrials.gov Guidance in Key Registry Data Fields (Paper)

This paper reveals the results of Patient Advisory Board (PAB) Meetings and a global online survey to obtain insight into the information preferences of people using a clinical trial registry in search for a clinical trial. Based on this data, the paper overviews a representative sample of current ClinicalTrial.gov entries and analyzed the extent to which they meet information preferences of people searching for a clinical trial for participation. In addition, we investigated the adherence of current records for brief titles and brief summaries to the guidance provided by ClinicalTrials.gov.

Patient Experience

Patient Protocol Engagement Toolkit (P-PET)

The Patient Protocol Engagement Toolkit (P-PET) is a comprehensive set of materials that sponsors and other stakeholders can use to engage patients during protocol development. The goal of this engagement is to improve patient experience and reduce patient burden as a study participant.

Patient Technology

Patient Technology Discussion Guide

For clinical study teams to consider when planning to implement patient technology. Helps organizations realize the full potential value of their implementation of patient technology by guiding them through the various stakeholder discussions and activities.

Patient Technology

Patient Technology Implementation Framework

Outlines a possible approach to patient technology implementation to help sponsors develop a holistic approach with patient technology within their own organizations. Shows how companies can use patient technology programs to build towards a unique vision using goals, metrics and important considerations.

Patient Technology

Patient Technology Regulatory Landscape Tool (U.S., EU, UK)

Collates U.S., UK, and European regulations and guidances related to digital health technologies and their use in clinical trials through December 2022. Helps organizations by providing critical information for use during regulatory strategy planning and Health Authority interaction planning.

Patient Technology

Patient Technology Shared Insights Knowledgebase (Paper)

A summary of key insights and findings from our collection of 81 cases of patient technology use in clinical trials. Intended to drive people to use the Shared Insights Knowledgebase, as well as highlight best practices and common barriers.

Patient Technology

Patient Technology Site Feedback Questionnaire

Developed to capture feedback from sites on their experience on using patient technology in clinical trials. Will help to improve dialogue between sites and sponsors and help improve future study design resulting from direct feedback on what works well.

Patient Experience

Showing Gratitude to our Clinical Trial Participants throughout the Clinical Trial Journey Infographic

Highlights how the Patient Experience Gratitude Toolkit can be used to show appreciation to patients and caregivers throughout their clinical trial journey and the potential benefits it may have to both patients and sponsors.

Diversity of Participants in Clinical Trials

Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity, and Inclusion of Participants in Clinical Trials (DEICT)

This toolkit is comprised of a set of mitigation considerations designed to support efforts to sustainably partner with sites to enable the enrollment and retention of underrepresented patient populations in clinical trials. These mitigation considerations consist of perspectives from a series of stakeholder discussions and a Diversity Roundtable event and suggest considerations across different maturity levels.

Patient Experience

Study Participant Feedback Questionnaire (SPFQ)

The Study Participant Feedback Questionnaire (SPFQ) is a survey provided to study participants at the beginning, middle and end of a clinical study. Use of the SPFQ is intended to improve patient centricity in clinical studies.

Patient Experience

Study Participant Feedback Questionnaire Toolkit Question Bank Addendum

Provides new and replacement questions for SPFQ Version 1.0, addressing motivation to participate, gratitude, and decentralized clinical trial activities.

eLabels

The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites and Sponsors Paper

The publication provides an overview of concepts, defines terminology and offers a discussion about the misconceptions related to the use of both eLabels and universal labels.

Diversity of Participants in Clinical Trials

U.S. Regulatory Landscape: Diversity in Clinical Trials

This regulatory landscape resource is designed to help identify key U.S. legislation and U.S. FDA policy, regulation, and guidance as well as regulatory precedent to consider when working to understand and improve diversity & inclusion (D&I) of adult patients in clinical trials, focusing on the inclusion of racial and ethnic minorities.

Patient Technology

Vendor and Sponsor Engagement Considerations Toolkit

A set of considerations developed with vendor insights to assist the facilitation of more routine two-way feedback discussions on the deployment of patient technology. The document is designed to help enable open discussion environments between parties where learnings can be shared, documented and leveraged for future studies.

Patient Technology

Vendor Gifographic

An engaging and insightful graphic describing key findings from surveys and interviews of patient technology vendors. Includes identification of industry challenges and ways to improve vendor and sponsor working relationships.

Clinical Research Access & Information Exchange

Layperson Summaries

Provides general priniciples helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation No. 536/2014.

This tool does not have each asset listed. For full access to resources in alphabetical order, click below.

Intelligent Automation Opportunities in Pharmacovigilance

2020 Technology Matrix

Provides information regarding the types of technologies available in pharmacovigilance and maps the level of implementation of each technology to the Individual Case Safety Report (ICSR) process.

Intelligent Automation Opportunities in Pharmacovigilance

Automation Opportunities in Pharmacovigilance: An Industry Survey (Paper)

This paper highlights opportunities and provides an initial starting point for companies considering ICSR process automation. Supplemented by the Interactive ICSR & Automation Technologies Tool (IATT).

Interpretation of Pharmacovigilance Guidances & Regulations

FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide & Webinar

An Implementation Guide to aide pharmaceutical manufacturers‘ understanding of ambiguous areas of the PMSR for Combination Products Draft Guidance for Industry and FDA Staff. In addition, a webinar presentation is included where TransCelerate team members provide an overview of the FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide.

Interpretation of Pharmacovigilance Guidances & Regulations

Global Pharmacovigilance Regulations: Call for Re-Harmonization Letter to the Editor of Journal of Clinical Trials (Paper)

A letter to the editor of Clinical Trials, noting a trend towards divergence of pharmacovigilance regulations. This letter is a call for re-harmonization to raise awareness of the issue and call for all stakeholders, in particular Health Authorities, to take efforts to re-harmonize.

Value of Safety Information Data Sources

Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient Safety (Paper)

Provides perspectives regarding hierarchy of value for collecting, processing, analyzing and reporting of adverse event information.

Intelligent Automation Opportunities in Pharmacovigilance

Interactive ICSR & Automation Technologies Tool (IATT)

An interactive tool that highlights opportunities and benefits for automation in the ICSR process and provides a visual representation of those opportunities.

Interpretation of Pharmacovigilance Guidances & Regulations

The Evolving Remit of the Reference Safety Information: Observations on Implementation of the 2017 Clinical Trials Facilitation Group (CTFG) Question & Answer Document

This manuscript highlights industry challenges in operationalizing the requirements of the 2017 Clinical Trial Facilitation Group (CTFG) Question & Answer document. Surveys reveal actions taken in the creation, submission and implementation of the Reference Safety Information (RSI) to meet the requirements of the CTFG and EU national competent authorities whilst staying compliant with global regulatory requirements.

Clinical Data Transparency

A Model Approach and De-Identification and Anonymization of Individual Patient Data in Clinical Studies (Paper)

Provides guidance and model approaches for redacting privacy information found in clinical study reports, anonymizing patient level data shared with the broader healthcare community and preparing and distributing layperson summaries to the general public and study participants. Now maintained by PHUSE.

eSource

Accelerating the Adoption of eSource in Clinical Research: A TransCelerate Point of View (Paper)

Provides a detailed assessment of the current state in the industry and opportunities to increase eSource adoption through four essential modalities.

Clinical Content & Reuse

Clinical Template Suite Implementation Toolkit

A set of tools to enable assessment and adoption of the Clinical Template Suite.

Clinical Content & Reuse

Common Clinical Study Report (CSR) – Basic Word Edition

Document template with common structure and proposed model content, aligned with ICH E3 and CORE. Integrates with CPT and SAP templates.

Clinical Content & Reuse

Common Protocol Template (CPT) – Basic Word Edition

Document template with a harmonized and streamlined approach to the format and content of clinical trial protocols. Includes common structure, proposed model content and participant and TA libraries.

Clinical Content & Reuse

Common Statistical Analysis Plan (SAP) – Basic Word Edition

Document template with common structure and proposed model content, aligned with ICH E9. Integrates with CPT and CSR templates.

Clinical Content & Reuse

CSR Considerations for Studies Disrupted by the COVID-19 Pandemic

Identified the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports to disruptions caused by COVID-19.

eSource

Data Mapping (FHIR-SDTM) for Labs, AEs, and SOA

Mapping of data elements between the HL7 FHIR standard and CDISC SDTM standard for labs, AEs, and SOA to enable interoperability between clinical data standards and healthcare data standards. Output was provided to HL7 to put through public comment.

Digital Data Flow

Digital Data Flow Communications Materials

Materials (DDF Overview, FAQs, CDISC Unified Study Definitions Model, GitHub page, and “What is Digital Data Flow?” video) to provide relevant stakeholders with a clear understanding of DDF's value proposition.

eSource

eSource Site Capability Questionnaire

Used by sponsors to help capture the site’s use of technology during the site qualification process. Intent is to facilitate the reduction of any administrative burden on sites by collecting information in a consistent manner.

Clinical Content & Reuse

eTemplates (eCPT, eCSR, eSAP)

The eTemplates are Word templates with technical functions to enable automation and clinical content re-use to downstream documents, processes, and registries.

eSource

Issues Related to Non-CRF Data Practices (Paper)

Practices and procedures for the collection and retention of non-CRF data are crucial to maintaining data accuracy and integrity. To guide the development of such practices and procedures, this paper outlines certain high-level best practices related to handling and managing non-CRF data.​

eSource

Optimizing the Use of Electronic Data Sources in Clinical Trials, The Landscape, Parts 1 & 2 (Papers)

These landscape assessments provide insight into sponsor company eSource activities and the environment affecting eSource adoption based on input from TransCelerate Member Companies, standards organizations, and regulatory authorities.

eSource

Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective (Paper)

Provides insights into the technological complexities, operational scope, and the actions required from pharmaceutical industry stakeholders to adopt the eSource framework for clinical research at scale.

Patient Technology

Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges (Paper)

This paper is a pharmaceutical industry perspective on opportunities and challenges with adoption and implementation of patient technology in clinical trials.

Clinical Research Awareness

Clinical Research Awareness: A Proposed Study Design to Assess the Role of Shared Decision Making in the Consideration of Clinical Trial Participation

This paper aims to enable researchers to assess the value and measures the impact of Shared Decision Making (SDM) on patient and HCP satisfaction.

Clinical Research Access & Information Exchange

Clinical Trial Registration Tool

A tool individual clinical trial sponsors can use to proactively evaluate the quality of the clinical trial registration data they submit to government-owned registries. Download to take a closer look at to leverage the Clinical Trial Registration Tool.

Diversity of Participants in Clinical Trials

Diversification Practices

Guidance for sponsors and clinical trial sites regarding better practices and processes for minority recruitment.

eConsent

eConsent Business Case

A customizable PowerPoint template available for Member Companies to support the creation of a business case for the implementation/adoption of eConsent.

eConsent

eConsent Implementation Guidance

Document outlining comprehensive, practical eConsent implementation approaches and considerations for sponsors and other interested parties. Developed through a collaboration with patients and sites, health authorities (HAs) and institutional review boards (IRBs)/independent ethics committees (IECs), and clinical research organizations (CROs).

eLabels

eLabels Concept Materials

Guidance on what factors to consider when designing a universal eLabel.

eLabels

eLabels Design and Delivery Toolkit

Implementation toolkit available on the TransCelerate external website providing guidance on voluntary implementation and to assist in Healthcare Authority engagements. Includes design, regulatory, technical and stakeholder considerations.

eLabels

eLabels Frequently Asked Questions

A document answering common questions around eLabels.

eLabels

eLabels Implementation Planning Tools

A series of guidance documents and planning tools to help support voluntary implementation planning for eLabels solutions.

eLabels

eLabels Technology Approach

Guidance on what factors to consider before implementing eLabels technology.

Clinical Research Awareness

Exploring the Impact of Shared Decision Making in Clinical Trial Consideration Paper

This paper explores shared decision-making in patient-provider conversations with the aim to enable patients to better understand clinical trials as a care option.

Clinical Research Access & Information Exchange

Improving Investigative Site Contact Options on Clinical Trial Registries: Making It Easier for Patients to Find Clinical Trials (Paper)

Paper offers guidance on a practical first step toward closing the gap between individuals willing to participate in clinical trials and the enrolling investigative sites for those trials, by making it easier to contact site locations through clinical trial registry listings.

Clinical Research Access & Information Exchange

Improving Investigator Site Contacts

Provides guidance on steps towards closing the gap between individuals willing to participate in clinical trials and the enrolling investigative sites for those trials, by making it easier to contact site locations through clinical trial registry listings.

Clinical Research Access & Information Exchange

Layperson Summaries

Provides general priniciples helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation No. 536/2014.

eConsent

Member Company eConsent Asset Value and Impact Case Study

Case study with empirical data to illustrate value and impact of eConsent assets for Member Companies, informed by aggregated Member company survey data regarding the usage and value of eConsent assets.

Clinical Research Awareness

One Person Closer Campaign

The photojournalist campaign aims to show doctors, nurses and other HCPs that they can help facilitate research that advances science and that may benefit their patients. 

Clinical Research Access & Information Exchange

Patient Communication Templates

Communication templates that sponsors may use, at their discretion, in order to facilitate exchanging information with clinical trial participants at the outset of clinical trial participation, during the trial and afterwards.

Patient Technology

Patient Considerations Toolkit

A set of considerations developed with input from patient discussions that when addressed (by sponsors) can result in improved patient experience using patient technology in clinical trials. 

Clinical Research Access & Information Exchange

Patient Preferences When Searching for Clinical Trials and Adherence of Study Records to ClinicalTrials.gov Guidance in Key Registry Data Fields (Paper)

This paper reveals the results of Patient Advisory Board (PAB) Meetings and a global online survey to obtain insight into the information preferences of people using a clinical trial registry in search for a clinical trial. Based on this data, the paper overviews a representative sample of current ClinicalTrial.gov entries and analyzed the extent to which they meet information preferences of people searching for a clinical trial for participation. In addition, we investigated the adherence of current records for brief titles and brief summaries to the guidance provided by ClinicalTrials.gov.

Patient Experience

Patient Protocol Engagement Toolkit (P-PET)

The Patient Protocol Engagement Toolkit (P-PET) is a comprehensive set of materials that sponsors and other stakeholders can use to engage patients during protocol development. The goal of this engagement is to improve patient experience and reduce patient burden as a study participant.

Patient Technology

Patient Technology Discussion Guide

For clinical study teams to consider when planning to implement patient technology. Helps organizations realize the full potential value of their implementation of patient technology by guiding them through the various stakeholder discussions and activities.

Patient Technology

Patient Technology Implementation Framework

Outlines a possible approach to patient technology implementation to help sponsors develop a holistic approach with patient technology within their own organizations. Shows how companies can use patient technology programs to build towards a unique vision using goals, metrics and important considerations.

Patient Technology

Patient Technology Regulatory Landscape Tool (U.S., EU, UK)

Collates U.S., UK, and European regulations and guidances related to digital health technologies and their use in clinical trials through December 2022. Helps organizations by providing critical information for use during regulatory strategy planning and Health Authority interaction planning.

Patient Technology

Patient Technology Shared Insights Knowledgebase (Paper)

A summary of key insights and findings from our collection of 81 cases of patient technology use in clinical trials. Intended to drive people to use the Shared Insights Knowledgebase, as well as highlight best practices and common barriers.

Patient Technology

Patient Technology Site Feedback Questionnaire

Developed to capture feedback from sites on their experience on using patient technology in clinical trials. Will help to improve dialogue between sites and sponsors and help improve future study design resulting from direct feedback on what works well.

Clinical Research Access & Information Exchange

Registry of the Future Wireframe

A proposal and wireframe mock-up, designed in conjunction with patients, illustrating patient-focused improvements for adoption to be incorporated into clinical trial registries to improve utility and access to clinical trial information.

Patient Experience

Study Participant Feedback Questionnaire (SPFQ)

The Study Participant Feedback Questionnaire (SPFQ) is a survey provided to study participants at the beginning, middle and end of a clinical study. Use of the SPFQ is intended to improve patient centricity in clinical studies.

eLabels

The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites and Sponsors Paper

The publication provides an overview of concepts, defines terminology and offers a discussion about the misconceptions related to the use of both eLabels and universal labels.

Patient Technology

Vendor and Sponsor Engagement Considerations Toolkit

A set of considerations developed with vendor insights to assist the facilitation of more routine two-way feedback discussions on the deployment of patient technology. The document is designed to help enable open discussion environments between parties where learnings can be shared, documented and leveraged for future studies.

Patient Technology

Vendor Gifographic

An engaging and insightful graphic describing key findings from surveys and interviews of patient technology vendors. Includes identification of industry challenges and ways to improve vendor and sponsor working relationships.

Clinical Research Access & Information Exchange

What Patients Want to See in Clinical Trial Registries Infographic

The infographic, based on a global patient survey with 1,070 responses, details what information is helpful when patients begin their search for clinical trials in a registry, and what information patients would like to see in the brief title and brief summary.

Comparator Network

Comparator Network

Web-based ordering system to execute comparator product transactions. Must be a Member of TransCelerate BioPharma.

Historical Trial Data Sharing

Historical Trial Data Sharing (Controls) DataCelerate®

Placebo/Standard of Care's new data home that will enable better searching and visualization of data shared among participating Member Companies.

Historical Trial Data Sharing

Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities (Paper)

As part of the continuing dialogue with Regulators, this paper aims to address the data selection methodology challenges, particularly when Placebo/Standard of Care is used to augment or substitute clinical control arms.

Historical Trial Data Sharing

Placebo/Standard of Care Adoption & Implementation Toolkit

A toolkit that describes lessons learned and best practices that can be adopted by participating Member Companies.

Historical Trial Data Sharing

Sharing Historical Trial Data to Accelerate Clinical Development (Paper)

A paper on sharing historical trial data to accelerate clinical development which highlights TransCelerate's Placebo/Standard of Care data sharing and DataCelerate.

Site Qualification and Training

Forms for Investigator Sites

A series of harmonized forms and templates leveraged across sponsors and used by investigator sites for critical clinical trial activities.

Site Qualification and Training

Good Clinical Practice Training Mutual Recognition Program

GCP Training Providers can self-attest to meeting minimum criteria based on ICH GCP guidelines which facilitates reduction in duplicative training for Investigator Sites by allowing potential mutual recognition across sponsor companies.

Site Qualification and Training

Informational Programs for Investigator Sites

A series of videos that describe the basic components of clinical research in accordance with the ICH Good Clinical Practice. Now owned by SCRS.

Investigator Registry

Investigator Registry

Alongside the Shared Investigator Platform, a combined solution providing accelerated identification of qualified investigators, facilitates site/sponsor interactions, and reduces administrative burden of clinical trial operations.

Shared Investigator Platform

Shared Investigator Platform

Alongside the Investigator Registry, a combined solution providing accelerated identification of qualified investigators, facilitates site/sponsor interactions, and reduces administrative burden of clinical trial operations. Now owned and maintained by Cognizant.

Quality Management System

A Knowledge Management Framework and Approach for Clinical Development (Paper)

Describes a framework for effective knowledge management within clinical development. Includes a suite of change management tools.

Common Serious Adverse Events (SAE) Fields

Common Serious Adverse Event Fields Overview & Outputs

A set of slides detailing the initiative’s background, its methodology for creating a core list of Common SAE Fields, and overview of the initiative’s outputs.

Risk Based Monitoring

Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Parts 1 & 2 (Papers)

These papers provide a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. Describes the initial implementation steps designed to learn what organizational capabilities are necessary.

Risk Based Monitoring

Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations (Paper)

Focuses on detecting data quality issues, irrespective of origin or motive.

Risk Based Monitoring

Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (Paper)

Assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of major and critical findings from TransCelerate member company internal audits.

Risk Based Monitoring

Integrated Quality and Risk Management Plan Framework

The IQRMP provides a tailored and integrated plan for a clinical trial that will include the clinical and medical risks identified at the program leveland assists in shared responsibility across all functions involved in collecting, analyzing and reporting clinical trial data.

Risk Based Monitoring

Measuring the Impact of Risk Based Monitoring (Paper)

Provides an overview of the TransCelerate RBM initiative’s original vision for specific metrics with the potential to effectively measure the value and impact of RBM from multiple perspectives and an analysis of how those original, suggested metrics have been put into realworld practice.

Quality Management System

Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development (Paper)

Describes a framework for effective processes management within clinical development. Assists organizations in understanding the benefits and basic components of process management for clinical development. Includes a suite of change management tools.

Protocol Deviations

Protocol Deviations Assessment Plan

A template to assist in the identification and documentation of protocol-specific "important" deviations.

Protocol Deviations

Protocol Deviations Map

A map of the protocol deviation management process containing processes for both important and non-important deviations.

Protocol Deviations

Protocol Deviations Process Guide

A proposed framework describing flexible protocol deviations management approaches, elements for consideration based upon proposed interpretation of the ICH E3 definition for important protocol deviations and other associated PD Guidance with links to the PD Process Map.

Quality Management System

Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development (Paper)

Describes a framework for effective risk management within clinical development. Assists organizations in understanding the benefits and basic components of risk management in clinical development. Includes a suite of change management tools.

Risk Based Monitoring

RBM Interactive Guide

A multi-chapter, interactive guide to all risk-based monitoring components.

Risk Based Monitoring

Risk-Based Monitoring Data Quality Management

"Implementation considerations for establishing quality tolerance limits (QTLs) and risk reporting in the clinical study report (CSR) are examined and described. This framework aims to be consistent with ICH E6 (R2) and TransCelerate papers on Risk Based Monitoring (RBM) and Quality Management System (QMS)."

Risk Based Monitoring

Risk-Based Monitoring Metrics Solutions/Change Tools

These tools delve deeper into the metrics for measuring RBM impact.

Risk Based Monitoring

Risk-Based Monitoring Risk Assessment and Categorization Tool (RACT) & Tools

A model approach to apply Risk-Based Monitoring, to direct monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality. Supported by a suite of tools to facilitate implementation, including a library of >100 risk indicators which sponsors may choose to apply in their clinical trials.

Risk Based Monitoring

Risk-Based Monitoring Technology Considerations (Papers)

Two papers hat delve deeper into the technology considerations of RBM.

Risk Based Monitoring

Site Level Risk Assessment Considerations

Provides examples to help demonstrate possible alternatives for quantifying initial and ongoing site level risk.

Risk Based Monitoring

Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct (Paper)

Explores a a cross-functional, collaborative approach to statistical monitoring that can adapt to study design and data source and use a combination of statistical screening techniques and confirmatory graphics.

Risk Based Monitoring

Technology Considerations to Enable the Risk-Based Monitoring Methodology (Paper)

Lays out the high-level considerations when designing and building an integrated technology solution that will aid in scaling the methodology across an organization’s portfolio.

Quality Management System

TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework (Paper)

Identifies methods for operationalizing in integrated QMS through which sponsors can systematically plan, control quality, monitor and improve performance in complex clinical research environments. Includes a suite of change management tools.

Quality Management System

TransCelerate’s Clinical Quality Management System: Issue Management (Paper)

Describes a framework for effective issue management within clinical development. Includes a suite of change management tools.