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Quarter 1 2021

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

  • BioCelerate’s SEND Harmonization Initiative published its second manuscript, co-authored in collaboration with the FDA as part of its Public-Private Partnership, in Chemical Research in Toxicology’s Computational Toxicology Special Edition. The article, “Leveraging the Value of CDISC SEND Datasets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals,” highlights the potential of SEND datasets for cross-study analysis and proposes solutions to address the challenges of doing so currently.
  • SCOPE 2021 finished on March 4 after three days filled with informative sessions related to the R&D and pharma industry. TransCelerate had the opportunity to present 10 sessions over the course of the conference covering many topics related to our solutions and initiatives. To read the in-depth recap of our sessions, click here.
  • We welcomed Andrew Hudson (Roche), who is the new Chair for the TransCelerate Pharmacovigilance (PV) Steering Committee. He will be taking over for Paul Chang (Johnson & Johnson), who we would like to thank for his dedication as Chair over the last two years. The innovative and synergetic energy he has brought to the committee during his time within TransCelerate’s leadership has been appreciated.

Pulse On Progress Updates

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.

  • Our Patient Experience Initiative has been diligently working to increase awareness and usability of critical deliverables such as the  Patient Protocol Engagement Toolkit (P-PET) and Study Participant Feedback Questionnaire (SPFQ). In participating with volunteers across the Country Network, the team is pleased to announce that there are now Japanese translations of the P-PET and more than 15 different translations of the SPFQ available for download on the Translated Solutions Webpage. Languages include: Spanish, Russian, Czech, Danish, French, Hungarian, Flemish, Polish, Slovakian, Korean, Japanese, German, Italian, Dutch, and English.
  • Our Site Qualification & Training Initiative had some exciting new changes to its Good Clinical Practice (GCP) Mutual Recognition website. As one of the most popular pages on our website, TransCelerate solicited input from the Training Provider community and determined there was a need for an update to address data quality issues, operational simplification, and outdated technology. This update will allow for automation of existing processes, improved user experience, and enhanced execution and oversight of the GCP Mutual Recognition Program.

Changes in this update include:


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 Intelligent Automation Opportunities (IAO) in Pharmacovigilance Initiative published an article through Drug Safety entitled, “Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices.” This position paper provides considerations to the industry on validation strategies that can be utilized for emerging AI-based automation technologies, while also outlining a risk-based approach to AI-static systems. It is intended to facilitate dialogue and collaboration with Health Authorities and industry on this topic and assist pharmacovigilance professionals by providing the knowledge to lead technology implementations within their organizations with considerations given to the building, implementation, validation, and maintenance of assistive technology systems.
  • The Value in Safety Information Data Sources (VSIDS) Initiative released a new infographic entitled, “Identifying the Value of Information Data Sources to Improve Patient Safety.” This infographic overviews study findings from two papers on the value of information data sources to improve patient safety and can be widely adopted for patient safety improvement.

Check Out Our Blog

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


The Spotlight

Intelligent Automation Opportunities in Pharmacovigilance 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.

April 7-9, 2021

Pharma: Clinical

Virtual Attendance

April 7-9, 2021

Patients as Partners U.S.

Virtual Attendance

April 20-22, 2021

SCRS European Site Solutions Summit 2021

Virtual Attendance

May 20-23, 2021

DIA China

Suzhou, China

May 24-27, 2021

Pharma SUG

Virtual Attendance

June 7-9, 2021

ARCS Annual Meeting

Sydney, Australia

June 14-18, 2021

PHUSE Connect US 2021

Virtual Attendance

June 27 – July 1, 2021

DIA Global Annual Meeting

Virtual Attendance


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