Query Resolutions / Site Support

The Challenge: An add-on study is required to determine the pharmacokinetic bioequivalence between two different drug formulations at identical dose strength. A delay in study results ultimately delays Health Authority approval. Enrollment has been met and final visit is approaching.

The Solution: Common queries from the original study are received from data management and covered with the CRA in advance of the final visit. Final visit is planned for the day of the final patient visit until database lock. Query trends are quickly discovered and curtailed by site staff. The collaboration between Site and CRA has become critical. CRA remained onsite until final data transfer and lock.

The Result: With data being transmitted immediately after last patient last visit, the CRA is able to assist the site with resolving the few final queries. The database locked and study data was transmitted to Health Authority within 5 days of final patient visit.