We were entrusted with the implementation of Post-Marketing Surveillance, including the creation of implementation guidelines, survey forms, facility contracts, patient enrollment, data management, statistical analysis, medical writing, and system development (EDC, progress management systems, etc.). We established a project manager to centrally manage the outsourced tasks and implemented strategies for the smooth progress of the surveys. This included devising and executing measures to address issues (such as approaching facilities experiencing progress delays, implementing measures to control re-surveys, etc.), ensuring high-quality and efficient survey operations.
Through being entrusted with multiple Post-Marketing Surveillance projects from the same client, we implemented measures to streamline and expedite operations. This involved the construction of standardizing procedures, accumulating and sharing knowledge for inquiry management, and overall efficiency improvement. Additionally, we conducted comparative analyses of evaluation criteria for each survey (such as the collection period for survey forms and re-survey forms), identified challenges, and implemented measures. This approach ensured a smooth progression of surveys.