TransCelerate BioPharma
Overview
TransCelerate BioPharma is a non-profit industry consortium of major pharmaceutical companies (20+ members including AstraZeneca, Bristol Myers Squibb, Eli Lilly, GSK, Johnson & Johnson, Novartis, Pfizer, Roche, Sanofi, and others) established in 2012 with the mission to improve the efficiency, quality, and cost-effectiveness of biopharmaceutical clinical research. Rather than competing on trial operations, TransCelerate members collaborate on shared challenges that affect the entire industry.
Key Programmes
Data Standards and Interoperability
The Common Protocol Template (CPT) is a standardised clinical trial protocol structure based on CDISC CDASH/SDTM that reduces protocol development time and variability. Digital Data Flow is an initiative to enable end-to-end digital, standards-based data flow from protocol through to regulatory submission. Data Exchange Standards promote CDISC SDTM/ADaM for regulatory submissions and facilitate data sharing between sponsors and CROs.
myTrials (Site Portal)
myTrials is TransCelerate’s shared investigator site portal providing a single interface for site staff to access documentation, training, and regulatory information across multiple sponsor companies, reducing the administrative burden on clinical trial sites.
Site Qualification and Feasibility
A shared site qualification database allows sites to complete one profile used by multiple pharmaceutical sponsors, reducing duplicate feasibility questionnaires.
Digital Pathology
TransCelerate has an active programme on digital pathology standards for clinical trial tissue biomarker assessments, working on image transfer and analysis standards aligned with DICOM and OME File Formats.
Decentralised Clinical Trials (DCT)
TransCelerate provides guidance on remote patient monitoring, telemedicine visits, and home nursing in clinical trials, developed in response to post-pandemic acceleration of decentralised trial models.
Connections
- Builds on: CDISC, DICOM, OME File Formats
- Registry: ClinicalTrials.gov
Resources
- https://www.transceleratebiopharmainc.com
- https://www.transceleratebiopharmainc.com/initiatives/ (full initiative list)