Additional Description:
The clinical data management offering spans the full study lifecycle. Start-up work covers protocol review, CRF creation, building the data management plan, and database setup — eCRF specification and programming, a data validation plan, edit/SAS check programming, dataset extraction and review, eCRF completion guidance, and a data review plan. Once the database goes live, site training follows. During the conduct phase, the team handles single and double data entry with validation, data cleaning, query management, serious adverse event reconciliation, and the integration, verification, and reconciliation of external data, plus data transfer agreements and medical coding against WHODrug and MedDRA. Closing activities include database lock, database finalization, resolving outstanding queries, collecting eCRF e-signatures, approving medical coding, completing documentation, producing CDASH-compliant exports and reports, and final database lock and archival.
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