In early February, TransCelerate had a highly engaging Annual Meeting with FDA colleagues to discuss our 2020 plans and look for promising ways to accelerate and evolve new areas of clinical research. By early March, the entire world—our industry included—went into shock as COVID-19 travelled the globe, hitting humanity in extraordinary ways. 2020 has impacted…
Welcome to TransCelerate
TransCelerate BioPharma Inc. is a non-profit organization with a mission to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.
Diversity of Participants in Clinical Trials
Racially and ethnically diverse populations have often been underrepresented in clinical trials, leading to persistent gaps between trial representation and real-world disease burden. Underrepresentation can limit confidence in future approved therapies and could potentially lead to unforeseen consequences among the impacted patient populations. TransCelerate’s new Diversity of Participants in Clinical Trials initiative will help to accelerate improvements by equipping sponsors and ecosystem stakeholders with the actionable tools and resources needed to improve the diversification of participants in clinical trials, which should ultimately improve patient outcomes.
Modernization of Statistical Analytics
A lack of evolution within the pharmaceutical industry’s analytic capabilities has given rise to inefficiency and a failure to leverage modern technologies within the clinical development space. Moreover, the limited regulatory perspective on this matter has become a barrier in implementing and leveraging newer analytical software capabilities. The Modernization of Statistical Analytics Initiative aims to analyze methods for considering and validating novel statistical computing platforms to propose to Health Authorities.
Beyond COVID-19: Modernizing Clinical Trial Conduct
The COVID-19 pandemic required swift implementation of innovative solutions to protect participant safety and enable clinical trial continuity. The pandemic catalyzed the expansion and acceleration of existing continuity solutions as well as the establishment of new ones. These continuity solutions should be extended beyond the pandemic to retain the benefits for participants and modernize clinical trials. This new white paper describes the broad categories of continuity solutions utilized, the challenges related to their use, and the factors that made implementation successful.
BioCelerate Continues to Help Improve Nonclinical Study Operations through Public Private Partnership with the FDA
BioCelerate, a subsidiary of TransCelerate BioPharma Inc. that focuses on identifying and developing pragmatic and tangible solutions to improve efficiencies in nonclinical research, has released the first set of its solutions as part of its Public Private Partnership (PPP) with the U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER) Office of Computational Science (OCS).
GCP Mutual Recognition
The TransCelerate Site Qualification and Training (SQT) Initiative has developed a Mutual Recognition (MR) Program for ICH E6 Good Clinical Practice (GCP) Training, targeted to investigator site personnel. Our GCP Mutual Recognition program was created to reduce redundant training and hours spent by investigators who need to complete the same training if they work with multiple sponsors.
TransCelerate Member Companies have translated select solutions for potential use within the broader global community. Current translations include solutions concerning Common Protocol Template, Site Qualification & Training, Quality Management Systems and Patient Experience.
- Welcome to TransCelerate
- Diversity of Participants in Clinical Trials
- Modernization of Statistical Analytics
- Beyond COVID-19: Modernizing Clinical Trial Conduct
- BioCelerate Continues to Help Improve Nonclinical Study Operations through Public Private Partnership with the FDA
- GCP Mutual Recognition
- Translated Solutions