The R&D ecosystem is tasked with developing medicines that will help improve the health of people around the world. Yet often the patients participating in clinical trials are not representative of the population impacted by the disease that is being studied. To safely bring medicines to all people, clinical trial processes need to evolve to…
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.
Join TransCelerate’s Awareness & Implementation Community
TransCelerate’s mission can only be realized when the benefits that stem from TransCelerate solution adoption are being felt by stakeholders across the R&D ecosystem. By signing up for this community, you’ll be the first to learn when: new solutions are available for download, educational webinars are being hosted by solution experts, impactful solutions testimonials are reported, and new tools are available to assist you on your awareness and implementation journey.
TransCelerate BioPharma Commences Collaborative Development of a Novel Digital Data Flow Solution for Study Start-Up
TransCelerate BioPharma Inc. (TransCelerate) announced on September 9 that it has commenced development on a reference implementation of a study definitions repository. The study definitions repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards.
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.
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
- Join TransCelerate’s Awareness & Implementation Community
- TransCelerate BioPharma Commences Collaborative Development of a Novel Digital Data Flow Solution for Study Start-Up
- Diversity of Participants in Clinical Trials
- Modernization of Statistical Analytics
- BioCelerate Continues to Help Improve Nonclinical Study Operations through Public Private Partnership with the FDA
- GCP Mutual Recognition
- Translated Solutions