Establishing or growing a Diversity & Inclusion (D&I) effort can be a daunting task, especially for smaller biopharma companies and organizations that may have a small or non-existent D&I department. However, this isn’t a topic that should be neglected. Even small changes implemented can have a lasting effect throughout the R&D ecosystem. Last year, TransCelerate…
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.
Digital Data Flow Launches Open Source SDR Reference Implementation
The Digital Data Flow Initiative released a Study Definition Repository Reference Implementation Minimal Viable Product, which is a model implementation of a repository that uses a Unified Study Definitions Model to facilitate data exchange. The source code and configurations are available by means of an open-source license, enabling pre-production deployments by solution providers or individual study sponsors.
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.
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.
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
- Digital Data Flow Launches Open Source SDR Reference Implementation
- Join TransCelerate’s Awareness & Implementation Community
- Diversity of Participants in Clinical Trials
- BioCelerate Continues to Help Improve Nonclinical Study Operations through Public Private Partnership with the FDA
- GCP Mutual Recognition
- Translated Solutions