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.
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TransCelerate has been actively monitoring the evolving COVID-19 crisis and we are providing our Member Companies a trusted and collaborative forum to discuss the ongoing disruption to drug development. TransCelerate Member Companies are using this informal forum to voluntarily discuss best practices and various options for addressing multiple drug development matters as the situation evolves.
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.
TransCelerate Expands COVID-19 Clinical Trial Data Sharing to Non-Member Companies
TransCelerate is expanding access to COVID-19-related patient-level clinical data sharing via DataCelerate® to non-member companies. In addition, TransCelerate will expand the type of data shared to include data from both the investigational product and control arms of COVID-19 clinical trials.
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.