# 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 - extends: [[CDISC]], [[DICOM]], [[OME File Formats]] - relatedTo: [[ClinicalTrials.gov]] ## Resources - https://www.transceleratebiopharmainc.com - https://www.transceleratebiopharmainc.com/initiatives/ (full initiative list)