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Quarter 3

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.

  • TransCelerate announced the commencement of development for a CDISC standards-based reference implementation of a study definitions repository on September 9. In collaboration with AccentureCDISC, and Microsoft, the open-source, vendor agnostic solution may facilitate end-to-end digital data flow between upstream study design systems (e.g., study builders, protocol authoring tools) and downstream systems and documents used to execute a trial according to the protocol. Read the full Digital Data Flow Initiative press release here.
  • The Clinical Content and Reuse team released their 2021 summary of changes. In this year’s release, users will find Clinical Template Suite (CTS) enhancements continuing in the areas of registry automation (ClinicalTrials.gov) and model content quality, incorporation of pandemic-related learning, estimand clarifications, as well as user-driven feedback on template clarity. On the technical side, updates were made to the eTemplates technical framework, along with enhancements to the template wizard experience and other authoring interface improvements. Updated solutions are now available on the CC&R Solutions page.

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 Technology Initiative’s Novel Digital Endpoints (NDE) manuscript was published in the Digital Biomarkers Journal, “Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations.” This paper summarizes key considerations (complemented with a case study) related to developing and navigating the path to Health Authority approval to use digital tools for NDE development in a clinical trial.
  • The COVID-19 pandemic challenged the way that healthcare and pharmaceutical industries deliver care to patients. It similarly challenged TransCelerate to think critically about the opportunities to provide help immediately and in the near future. As such, the Patient Experience Initiative was one of the teams recognized as having produced valuable solutions with applicability to the changing industry landscape, which included caregivers playing a more integral role in the clinical trial process and a shift to fully virtual engagements. The team updated two key solutions, the Patient Protocol Engagement Toolkit (P-PET) User Guide and the Patient Protocol Engagement Toolkit (P-PET) Resource Guide, to include new considerations related to caregivers in clinical trials as well as best practices for engaging patients and caregivers in a virtual environment. These updated solutions are now available on the Patient Experience Solutions page.

Enhance Sponsor Efficiencies
Objectives

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


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 Pharmacovigilance Agreements Optimization Initiative team collected public feedback on the TransCelerate PVA Table of Contents (TOC) from August 16 to October 18. The TOC offers a framework of modules, headings, and points to consider, and was developed in the context of sponsor to sponsor, or marketing authorization holder (MAH) to MAH.

Check Out Our Blog

Learn about what we’ve been up to this past quarter:

The Latest

Navigating the Development of Novel Digital Endpoints

The Spotlight

TransCelerate’s Privacy Framework for Clinical Data Reuse

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 through Q4. For detailed information on speaker presentations, visit the events page on the TransCelerate website.

November 2-4, 2021

Pharma & Patient USA 2021

Virtual Attendance

November 2-4, 2021

Clinical Trials EU

Virtual Attendance

November 5, 2021

RQA (Research Quality Association) Conference

Virtual Attendance

November 8-10, 2021

International Society of Pharmacovigilance Annual Meeting

Virtual Attendance

November 16, 2021

Webinar: Digital Data Flow: Modernize Clinical Trials by Enabling a Digital Workflow

Virtual Attendance


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