Clinical Trial Data Management overview

Manages the end-to-end lifecycle of clinical trial data -- ingesting electronic case report forms from investigator sites, enforcing protocol-specific validation rules, reconciling laboratory and imaging data with clinical observations, running edit-check queries against CDISC/SDTM standards, and generating submission-ready datasets for regulatory authorities. Produces validated trial databases, discrepancy reports, and data lock certification. Excludes protocol design and patient recruitment.