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A digitised clinical-trial OPERATIONS dataset accrued as byproduct of Advarra's own IRB and clinical-trial-management systems: 170,000+ protocol-related documents and operational records from 30,000+ studies across 3,500+ sponsors. Contents include full protocol design structure (eligibility criteria text, schedule of assessments, visit procedures and endpoints), longitudinal protocol-amendment history with the reason behind each amendment, regulatory-review and study-startup milestone cycle times, enrollment trends and attainment, and site-level performance (enrollment ease or difficulty, competition for patients, repeatability). Harmonised to standardised ontologies across systems, and by design contains no clinical or patient-identifiable data — it is study metadata and aggregated operational data.
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