March 10, 2023
Participant Data Return Initiative Overview Deck
Provides an overview of the Participant Data Return initiative and its current solutions
Explore
mc-resource
February 24, 2023
Rapid Analysis of RWD Safety Signal Assessment: Current State Findings
This webinar shares the outcomes of a current state assessment conducted by the TransCelerate Initiative, "Rapid Use of RWD for Signal Assessment" (RSA-RWD). The current state assessment included both a Member Company survey and literature review. In addition to focusing on where rapid use of RWD for safety signal assessment is currently being used, this current state assessment was leveraged to identify opportunities for its further use in signal assessment to enhance patient safety and public health.
Explore
January 19, 2023
Initiative Overview IGR Clinical: ICH E8-E6
An overview of the ICH E8/E6 topic within IGR Clinical.
Explore
December 13, 2022
Rapid Safety Assessment Using RWD Current State Survey Assessment
The intent of this survey is to understand the current state of use of rapid RWD analyses for signal assessment in the light of feasibility, speed, and regulatory requirements. Further, the survey was leveraged to identify potential opportunities and approaches to complement signal assessment by rapid analysis of RWD to help overcome resource and time constraints and to potentially enhance patient safety and public health.
Explore
September 15, 2022
TransCelerate Member Best Practice Sharing: Patient Technology Framework
Explore
September 13, 2022
PVAO Initiative Overview Deck
This overview provides background on the PV Agreements Optimization (PVAO) initiative which seeks to produce a customizable, interactive resource for new and experienced contract partners, which could be used to inform and/or streamline their PVA process development, contract drafting, and negotiations.
Explore
June 29, 2022
Road Map Education – Value Story – Augment Control Arm in Phase 3 Trial – Clinical Data Sharing
Member Company end user shares the application of Historical Trial Data (HTD) in a control arm supplementation use case, highlighting the opportunity and challenges of using this data, and learnings from health authority discussions. Not for circulation outside member companies.
Explore
June 29, 2022
Road Map Education – TransCelerate Board Member Remarks – Clinical Data Sharing
In the opening segment for the 2021 MC Symposium session on Real Life Applications of Historical Trial Data, John Oidtman, a former TransCelerate Board Member, shared his passionate perspectives of the moral obligation, direct member value, and practical impacts to patients when HTD is used in clinical development. Not for circulation outside member companies.
Explore
June 8, 2022
Road Map Education – The Journey – Clinical Data Sharing
Discussion of the multi-year journey and learnings of building a Clinical Trial Data Sharing capability at TransCelerate, presented by Steering Committee Leader Jules Desmond, Amgen. Not for circulation outside member companies.
Explore
June 3, 2022
CT.Gov Beta Website Feedback
22 Website Functionality proposed improvement opportunities TransCelerate highlighted in the RFI from 2021 to revamp the ClinicalTrials.gov website. In addition to describing what part of the website each proposed improvement opportunity falls under, you will also find the status of incorporation as well as any proposed next steps TransCelerate identified where appropriate.
Explore