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URL: http://www.transceleratebiopharmainc.com/
Proper Citation: TransCelerate BioPharma (RRID:SCR_003728)
Description: A non-profit research organization aiming to accelerate drug development by increasing the quality and efficiency of clinical studies through the development of shared tools, methods, and platforms. Consortium partnerships are limited to pharmaceutical and biotechnology companies with research & development operations, although there are collaborations with external organizations such the Clinical Data Interchange Standards Consortium (CDISC). Its current focus is to collaborate on: * Standardizing risk-based monitoring * Development of methods to qualify and train clinical trial sites * Development of a common investigator web portal * Development of clinical data standards on efficacy, and methods for comparator drug trials It currently has 5 projects: # Standardized Approach for High-Quality, Risk-Based Monitoring program aims to develop an industry-wide standard and approach for risk-based monitoring of clinical trials in order to enhance patient safety and ensure the quality of clinical trial data. # Shared Site Qualification and Training program aims to standardize GCP training and site qualification credentials in order to realize efficiencies and accelerate study start-up timelines. # Common Investigator Site Portal is a platform designed to streamline investigator and site access through harmonized delivery of content and services. # Data Standards project is a partnership with CDISC to develop industry-wide data standards in priority therapeutic areas to support the exchange and submission of clinical research and meta-data, improving patient safety and outcomes. # Comparator Drugs project aims to establish reliable, rapid sourcing of quality products for use in clinical trials through a comparator supply model enabling accelerated trial timelines and enhanced patient safety.
Abbreviations: TransCelerate
Synonyms: TransCelerate BioPharma Inc.
Resource Type: portal, consortium, organization portal, data or information resource
Keywords: drug, clinical trial, multipharma, data sharing, drug development, consortium, medicine, clinical, standard specification
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