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Quarter Q4

Pulse on Progress

Table of Contents

Introduction

TransCelerate aspires for a future state where research and development is faster, more efficient and harnesses all the available information. We envision this happening in three ways:
  1. Full participation across all stakeholders — clinical trial sponsors, sites, investigators, patients and their healthcare providers
  2. Information is fully used to improve the overall quality, design and development process. We protect patients through shared, proactive safety science
  3. Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials

Newest Resources and Company Milestones


Pulse On Progress Updates

Information Sharing & Harmonization
Objectives

Enable the industry to move toward greater harmonization of process and facilitate the sharing of information amongst industry stakeholders to enable the industry to capture, optimize and experience efficiencies.

  • The Clinical Content & Reuse (CC&R) Initiative launched its 2020 release, including an updated CC&R Initiative website and Solutions Page. Key changes include updates that provide more focus on how the Clinical Template Suite (CTS) and tools enable content reuse across the clinical development ecosystem, updates to template content in alignment with ICH E9 (R1), updates to eTemplates, and enhanced patient centricity and ClinicalTrials.gov registration, which was done in partnership with the Clinical Research Access Initiative.
  • The DataCelerate® & Historical Trial Data (HTD) Sharing Initiatives launched a new DataCelerate module for sharing COVID-19 data. This module replaces an existing COVID-19 file share solution launched in April with several key improvements, and it is open to participating members of TransCelerate, as well as qualifying non-member biopharma and government biomedical research agencies. Participating companies may make anonymous requests for COVID-19 relevant studies from other participating companies directly through the DataCelerate platform. For more information, read our blog post: How the Pharmaceutical Community is Powering the Sharing and Reuse of Data.

Improve the Patient & Site Experience
Objectives

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

  • The Patient Experience Initiative released an infographic outlining why and how the Patient Protocol Engagement Toolkit (P-PET) and Study Participant Feedback Questionnaire (SPFQ) Toolkit were created with patient advisors and R&D experts. View the infographic here.
  • The Patient Experience Initiative also released the Patient Protocol Engagement Toolkit translated to Japanese located under Solutions Available in Additional Languages.
  • The Modernizing Clinical Trial Conduct Initiative 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. The topics of the workshop included telemedicine, shipping, home health visits and local lab usage. To read more about the workshop and its findings, click here.

Enhance Sponsor Efficiencies
Objectives

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

  • The Interpretation of Clinical Guidances & Regulations: GDPR Data Reuse topic team released a new solution and supporting materials, all focused on addressing the uncertainty surrounding the European Union’s General Data Protection Regulation (GDPR) with respect to data reuse. Read their solution, A Privacy Framework for Clinical Data Reuse: Secondary Data Use in the Pharmaceutical Industry, its supporting materials, and watch the overview video.
  • The Interpretation of Clinical Guidances & Regulations: Quality Tolerance Limits (QTL) topic team released several solutions to help Sponsors experiencing challenges with interpreting and operationalizing QTLs, including a Quality Tolerance Limits Framework, infographic and Demystifying Quality Tolerance Limits Webinar. These solutions were developed in response to the E6 R2 guidelines published by ICH in 2016, which introduced risk-based approaches to quality management for clinical development, including the concept of Quality Tolerance Limits. To view all the team’s full list of solutions, visit its website.
  • The Quality Management System (QMS) Initiative released an infographic highlighting examples where Member Companies found significant value implementing a Clinical QMS framework for clinical research.

Enhance Drug Safety
Objectives

Facilitate solutions that address a common set of challenges in drug safety surveillance such as engaging the public, collaborating with regulators, incorporating data and analytics, developing model approaches, and assessing the impact of efforts.

  • The Intelligent Automation Opportunities in Pharmacovigilance Initiative launched a video for the Interactive ICSR and Automation Technology Tool (IATT). The solution depicts each process step within the Individual Case Safety Report (ICSR) process, and the video demonstrates how the tool can be used and adopted. Watch for an overview of what IAO is, information on the creation of the IATT and lastly, a step-by-step guide on how to navigate the interactive website features of the IATT.
  • The TransCelerate Interpretation of Pharmacovigilance Guidance & Regulations (IGR PV) Presentation of Safety Risks Throughout the Lifecycle (PoRTL) topic team released its new solution: “A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle.” Developed in accordance with relevant Health Authority guidances, this framework provides an outline of regulatory requirements and considerations for presenting risks within key safety related regulatory documents required at the various product lifecycle stages. For more on this framework and to watch its accompanying video, click here.

The Latest

The Importance of Harmonizing Clinical Trial Content, Especially in a Post-Pandemic World

The Spotlight

The Historical Trial Data Sharing Initiative

Mark Your Calendars

TransCelerate leaders and Member Companies are invited to participate and present at many biopharmaceutical research industry conferences and meetings across the globe to provide a perspective on industry challenges and clinical trial issues. Take a peek at a few places we will be presenting early next year. For detailed information on speaker presentations, visit the events page on the TransCelerate website.

March 2-4, 2021

SCOPE US

Virtual Attendance

March 12-25, 2021

Society of Toxicology Annual Meeting

Virtual Attendance

March 15-19, 2021

DIA Europe

Virtual Attendance


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