TransCelerate has published risk-based monitoring (RBM) recommendations for central monitoring and technology considerations. Two manuscripts published in the Drug Information Association’s Therapeutic Innovation & Regulatory Science journal, provide in-depth insights into these concepts pertinent to RBM methodology. Access to the two new manuscripts, the RBM methodology, subsequent updates and related materials can be viewed here.
Training Providers – To have your GCP training added to the list of those programs mutually recognized by TransCelerate Member Companies, please find information here.
Sites – To find common Sponsor forms mutually recognized by TransCelerate Member Companies and instructions for completion, please visit here.
Our ten visionary founding members launched TransCelerate to “increase quality in clinical studies and improve patient safety, enabled by broad participation and collaboration across the global research and development community.” They have since been joined by nine additional members, dedicated to accelerating the development of new medicines.
Learn more about our members here.
Launched in September 2012, TransCelerate Biopharma Inc. aims to simplify and accelerating the delivery of innovative medicines to patients. With so much progress and so much future opportunity, we have continued to refine our focus. The new statements below reflect our organization’s continued commitment:
To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.
To collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines.
Our Core Values
Resources for Sites and Training Providers, including common Sponsor forms and criteria for GCP training that are mutually recognized by TransCelerate Member Companies, are available by clicking the button below.
TransCelerate executives and members present at many industry conferences and meetings all across the globe. Click on the button below to see a comprehensive list of these events.
The Clinical Data Interchange Standards Consortium (CDISC) and TransCelerate have announced the availability of therapeutic area (TA) standards for diabetes and cardiovascular (CV) disease areas through the Coalition for Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C-Path). Read more here.
TransCelerate has published a recommendation for examining the value of Source Data Verification (SDV) in risk-based monitoring. Through a comprehensive literature review, a retrospective analysis of data in clinical trials, and an assessment of major/critical findings from audits, the authors conclude that SDV (transcription checking) has limited value as a quality control measure. The manuscript […]
During the 2014 RAPS: The Regulatory Convergence conference (29 September), Janet Woodcock, director of the US Food and Drug Administration’s Center for Drug Evaluation and Research, spoke to attendees via a pre-recorded video during a session titled, “Focusing on the Patient: Advancing Innovation Through TransCelerate.” Woodcock covered some important initiatives and changes in drug development and regulation […]