BACKGROUND: COVID-19 global health emergency revealed the need for pharmacovigilance projects to proceed rapidly while guaranteeing high-quality standards. Post-authorization safety studies (PASS) are complex and mandatory pharmacovigilance activities that require the participation of specialized scientific project managers at every stage, from scientific and regulatory affairs consultancy to change management readiness. During the COVID-19 pandemic, the undeniable contribution of scientific project managers in pharmacovigilance activities enhanced the ability of study consortia to adapt to rapidly evolving regulatory requirements on top of the existing challenges.
OBJECTIVES: To identify and describe coordination and management challenges in the design and execution of PASS studies that emerged during the COVID-19 pandemics and develop methodological procedures for agile management whilst addressing regulatory requirements.
METHODS: We retrospectively reviewed PASS workflows and tasks from the initial request stage to the final reporting and archiving; we analyzed the impact of COVID-19 pandemics in the different aspects of studies management including study governance, protocol development, data management and protection, reporting, quality, and risk management.
RESULTS: We established, adopted, and validated high-reliability organizational principles and methodologies, such as good management practices, effective communication systems, actions as a learning partnership to optimize scientific project management processes of PASS studies and address the following needs:•Availability of updated data•Data harmonization and integration•IRB approvals during pandemics•Rapidly changing regulatory requirements•Fast-trackreporting methodology•Accurate validation process of AESIs
CONCLUSIONS: The role of scientific project management is crucial for successfully conducting PASS projects. The management ofuncertainty, rapidly changing regulatory environment, stakeholders' collaboration, change management, continuous improvement through the creation of effective tools, flexibility, and prioritization were identified as key factors for the successful coordination of PASS studies during the pandemic. Beyond this, scientific project managers also contribute to shaping and improving studies technical aspects, such as study implementation, data collection and reporting throughout the continuous support and monitoring alongside the study scientific coordinator.
