Integrating Data from 25 Clinical Trials for Treatment of Anxiety

Premier Research designed and built a data warehouse by integrating data from over 25 clinical trials in support of a drug to treat anxiety for a Top 5 Pharmaceutical company. The strategic design, architecture and topology of the data repository were critical in facilitating the detailed statistical analyses required to support the FDA filing. Additionally, the design of the data repository documentation, including the programs designed for data mining, allowed seamless verification and reconciliation of the process. In addition to designing and building the data repository, Premier Research also coded all of the adverse events using MedDRA, generating a straight-forward audit trail for the ISS. Premier Research delivered all project deliverables, including the ISS with complete tables and listings, both on time and within budget.

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