Sponsor Efficiencies

July 15, 2020

Integrated Quality and Risk Management Plan Framework

The IQRMP provides a tailored and integrated plan for a clinical trial that will include the clinical and medical risks identified at the program leveland assists in shared responsibility across all functions involved in collecting, analyzing and reporting clinical trial data.

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July 15, 2020

Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (Paper)

Assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of major and critical findings from TransCelerate member company internal audits.

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July 15, 2020

Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations (Paper)

Focuses on detecting data quality issues, irrespective of origin or motive.

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July 15, 2020

Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Parts 1 & 2 (Papers)

These papers provide a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. Describes the initial implementation steps designed to learn what organizational capabilities are necessary.

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July 15, 2020

Common Serious Adverse Event Fields Overview & Outputs

A set of slides detailing the initiative’s background, its methodology for creating a core list of Common SAE Fields, and overview of the initiative’s outputs.

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