mc-resource

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.

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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.

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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.

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May 25, 2022

Best Practices to Stand Up a Data Sharing Capability within Member Companies

Data Sharing can be a complex but powerful capability with the right organizational culture, infrastructure, governance and processes. This session will showcase Member Companies' best practices and success stories in setting up an effective data sharing capability within their organizations. These learnings can be applied to strengthen one’s own effectiveness in data sharing.

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May 25, 2022

Real-Life Applications of Historical Trial Data to Drive R&D Strategy and Study Design

Reuse of clinical trial data can be an invaluable asset that is readily available to enhance decision making across the R&D value chain. In this session, we will hear of real-life applications of Historical Trial Data and how it impacted clinical development.

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May 17, 2022

Transcelerate RWD Audit Readiness: Data Service Provider Survey – Detailed Report

The intention of the survey is to help answer the question: ‘What should sponsors and organizations who provide RWD for research purposes consider when preparing for audits in order to help establish relevance and reliability of RWD in a way that is meaningful to regulatory auditors?' from the perspective of organizations who provide RWD for research purposes.

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May 6, 2022