Our Vision, Mission and Core Values

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:

Our Vision

To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.

Our Mission

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

Transparency & Openness
Trust & Integrity

Learn More

For Sites & Training Providers

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.

Learn More

Our Events

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.

Learn More

Latest News

CDISC and TransCelerate Announce Availability of New Diabetes and CV Disease Standards

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 Publishes Rec on Use of Source Data Verification in RBM, Releases Update on Initiative Progress

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 […]

2014 RAPS Video Featuring Janet Woodcock

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 […]