In vivo efficacy studies generate critical data for drug discovery, but the absence of agreed standards leads to fragmented, inconsistent, and difficult-to-reuse data sets. Current approaches rely on bespoke formats across pharma, CROs, and technology providers, making integration, regulatory submission, and AI-driven analysis inefficient and error-prone. While CDISC SEND provides a proven framework for toxicology studies, no equivalent exists for efficacy studies, leaving a standards gap that slows research and reduces the value of pre-clinical data.
By advancing practical, pre-competitive standards for in vivo efficacy data, aligned with CDISC SEND and piloted across real-world data sets, the project will improve data quality, interoperability, and regulatory and analysis readiness.
To discover more about our initiative click here.
Speakers
- Chris Butler, Research Fellow, Abbvie
- Tim Letby, Director, R&D IT – Data, Analytics & AI , Astrazeneca
- Andrew Smith, Scientific Solutions Consultant, Benchling
- Marc Ellison, Director, SEND Solutions, Instem
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