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.

TransCelerate Biopharma’s Privacy Methodology for Data Reuse Initiative has developed a proposed privacy methodology to improve quality of the clinical trial data exchanged within TransCelerate’s Clinical Data Sharing via DataCelerate® while protecting patient privacy. TransCelerate would like to invite the public to provide their perspectives and reviews on the guidance and checklist in this proposed methodology.

2022's annual report details all that TransCelerate BioPharma and BioCelerate have achieved in the past year in our preclinical, clinical, and pharmacovigilance portfolio.

Janice Chang has been appointed as TransCelerate’s new Chief Executive Officer. Currently serving as Chief Operating Officer, Janice will assume the role on January 1, 2023. She will also serve as CEO of BioCelerate.

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.

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.