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.
Common queries from the original study are received from data management and covered with the CRA in advance of the final visit. The 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 the site and the CRA has become critical. CRA remained onsite until final data transfer and lock.
With data being transmitted immediately after the last patient visit, the CRA is able to assist the site with resolving the few final queries. The database locked and study data was transmitted to the health authority within five days.