Indegene helped a global CRO streamline clinical trials data collection by automating eCRF creation for EDC systems using its NEXT Study Build Automation—an AI/ML and NLP-powered solution. Challenges included poor-quality eCRFs from traditional methods causing process inefficiencies, lack of global standardization, and difficulties mapping eCRF variables to SDTM. Indegene's software ingested and analyzed protocols, recommended best-fit eCRF standards across phases and indications, enforced consistency, simplified variable mapping, and accelerated builds. This eliminated inefficiencies, ensured high-quality data capture, and optimized trials for multiple studies.

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