TransCelerate membership is available to pharmaceutical/biopharmaceutical companies with R&D organizations who engage in innovative discovery, development, and manufacturing of new drugs. Membership is limited to companies; we do not offer membership to individuals. Our Members
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Featured Solution: Comparator Network As part of the close-out of activities for a Phase III trial, we managed to donate to a patient in Ukraine that was under standard of care treatment that could no longer be supplied under study sponsor responsibility, a batch of all our remaining and compliant treatment. This supported the patient…
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TransCelerate’s efforts have had a transformative impact on the entire R&D ecosystem. Visit our library of Solution Implementation Experiences. Since 2012, TransCelerate has designed, developed, and delivered 525+ solutions and implementation tools1. Most of these are free for public download and use. 1 – Numbers based on data from 2022 TransCelerate portfolio delivery Solution Implementation Experiences TransCelerate…
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Blog December 2, 2020
This is the first article in a five-part blog series about TransCelerate’s data sharing initiatives. This first piece will explore the foundations of our data sharing work. Future topics in this series will include our work on data sharing to support a robust response to COVID-19, patient privacy, and toxicology, among others. TransCelerate BioPharma was…
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Solution
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has finalized the ICH GCP Guidelines ICH E6(R3). The ICH reflection paper states the “goal [of this guidance] is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources that are…
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Blog March 11, 2021
This is the second article in a five-part blog series about TransCelerate’s data sharing initiatives. Future topics in this series will include our work on data sharing to support a robust response to COVID-19, patient privacy, and historical trial data sharing, among others. The value chain of developing new medicines to treat complex diseases in…
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Initiative
TransCelerate’s Comparator Network establishes a reliable, rapid sourcing of quality products for use in clinical trials for participating Member Companies to avoid counterfeiting and avoid delays in study start-up.
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Solution - subpage
The eConsent Implementation Guidance provides information about how to determine whether eConsent is a feasible approach, which eConsent multimedia components are a reasonably good fit for a specific study, and the external and internal processes to consider when implementing. The eConsent Implementation Guidance does not provide sample consent language, standards, or requirements. As eConsent becomes more widely used,…
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Solution
The Pharmacovigilance Agreements Optimization (PVAO) Initiative is focused on developing solutions and accompanying tools to address challenges across the lifecycle of pharmacovigilance agreements (PVAs). With the increasing volume and complexity of PVAs, the need for simplification and efficiency is greater than ever. Our suite of solutions is designed to be adaptable and flexible to support…
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Solution
Intelligent Automation Opportunities in Pharmacovigilance Initiative is focused on identifying opportunities for utilizing different types of intelligent automation technologies to improve industry PV process quality, efficiency, and PV data insights, ultimately to improve PV work for patient safety. As of April 2025, this initiative is complete. No new solutions or updates are planned.
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