Crowdsource UAT: An Opportunity for Future Validation

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Event overview

Validation of eTMF features and functionalities is a requirement for electronic Trial Master Files (eTMF) per FDA CFR 21 Part 11, ICH GCP E6 (R2) and the EMA, initially for implementation and subsequently with each upgrade thereafter. As new features are introduced, the scope of work for validation for each upgrade can increase for an eTMF owner.
CrowdSource User Acceptance Testing offers an opportunity to minimize eTMF validation workloads. This presentation will demonstrate how eTMF vendors can utilize CrowdSource as a UAT model to support their clients, by driving joint cross-client UAT exercises during upgrade cycles.

Darshan Patel
Associate Director of Customer Success for eTMF
IQVIA

Darshan Patel leads a team responsible for client relationships, training needs, system upgrades, and migrations. He has significant clinical experience in both CRO and sponsor settings and in several GXP environments. With more than a 5-year focus in the TMF/eTMF space, Darshan has worked across multiple therapeutic areas, including oncology, asthma, schizophrenia, and dementia. He is a frequent speaker at industry conferences focused on clinical quality and compliance.

Darshan earned a Bachelor of Science degree in Biomedical Sciences from St. George’s, University of London, and a Master of Science degree in Clinical Drug Development at Queen Mary University of London.

Speaker’s Email: darshan.patel@iqvia.com
Speaker’s LinkedIn: https://www.linkedin.com/in/darshanpateluk/

For any technical questions please contact Jordan Ramesh: jramesh@mjhlifesciences.com

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Crowdsource UAT: An Opportunity for Future Validation

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