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Our Solutions

Strategic Programs

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

Enhance Drug Safety

Helps the management of the volume, variety and velocity of pharmacovigilance data and addresses the lack of automation and technology to aid the patient safety space.

Enhance Sponsor Efficiencies

Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.

Harmonize Process

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

Improve the Patient Experience

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

Improve the 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.

Share Information

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

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.

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.

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.

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.

Data Monitoring Committee

Data Monitoring Committee Apprentice Model

Mentoring framework which defines a model for enabling seasoned DMC members to aid new DMC candidates in gaining relevant experience.

Data Monitoring Committee

Data Monitoring Committee Registry Concept Video

Visual representation of a publicly available and searchable DMC registry. Demonstrates how DMC organizers would connect with DMC candidates.

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 Communications Materials

Materials (DDF Executive Summary, DDF Problem Statement & Future State Narrative, 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 Solution Framework & Conceptual Design

Describes a potential Solution Framework and Conceptual Design that will help technology providers create an innovative, central protocol platform that will be accessible, open, flexible and vendor-agnostic toward downstream clinical applications.

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.

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.

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.​

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Clinical Trial Diversification

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 Global Landscape Assessment

Global map and detailed reports based on blinded and aggregated data about industry experience providing information on trends in the global 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 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.

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 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

Collates U.S. and European regulations and guidances related to digital technologies and their use in clinical trials. 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

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

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.

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.

Data Monitoring Committee

Data Monitoring Committee Apprentice Model

Mentoring framework which defines a model for enabling seasoned DMC members to aid new DMC candidates in gaining relevant experience.

Data Monitoring Committee

Data Monitoring Committee Registry Concept Video

Visual representation of a publicly available and searchable DMC registry. Demonstrates how DMC organizers would connect with DMC candidates.

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.

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 Executive Summary, DDF Problem Statement & Future State Narrative, 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 Solution Framework & Conceptual Design

Describes a potential Solution Framework and Conceptual Design that will help technology providers create an innovative, central protocol platform that will be accessible, open, flexible and vendor-agnostic toward downstream clinical applications.

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.

Clinical Trial Diversification

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 Global Landscape Assessment

Global map and detailed reports based on blinded and aggregated data about industry experience providing information on trends in the global 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

Collates U.S. and European regulations and guidances related to digital technologies and their use in clinical trials. 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.

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.

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.

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