April 20, 2023
This survey addendum was conducted to gain additional insight from responding companies of the original survey to understand better whether there might be dependencies between certain practices in rapid RWD analyses for signal assessment regarding the type of analyses performed, type of documentation used, and maximum acceptable timeframes for delivery.
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April 11, 2023
Provides an overview of the Rapid Signal Assessment Using RWD initiative and its solutions.
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March 10, 2023
Provides an overview of the Participant Data Return initiative and its current solutions
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September 15, 2022
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September 13, 2022
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.
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June 3, 2022
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 17, 2022
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
TransCelerate Member shares their experience and best practices for the Clinical Study Report (CSR) and Lean Writing Principles
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May 6, 2022
TransCelerate Member shares their experience and best practices for the Clinical Study Report (CSR) and Lean Writing Principles.
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May 6, 2022
TransCelerate Member shares their experience and best practices for the Clinical Study Report (CSR) and Lean Writing Principles.
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