Pharmacovigilance and Regulatory Affairs

Pharmacovigilance Compliance in Clinical Trials

Pharmacovigilance in clinical trials plays a critical role in ensuring the safety of participants and maintaining regulatory compliance throughout drug development. Regulatory agencies mandate robust safety oversight during trials, requiring timely reporting of adverse events, serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs). Sponsors must implement risk-based monitoring, standardized case reporting, and transparent communication with investigators and ethics committees. The use of electronic data capture systems, centralized monitoring, and automated alerts strengthens early signal detection and supports regulatory obligations. Collaboration between clinical operations, medical monitors, and safety teams ensures accurate causality assessments and adherence to protocol requirements.

Maintaining compliance involves detailed documentation, proper training, and alignment with ICH-GCP, FDA, and EMA standards. Non-compliance can result in trial delays, regulatory penalties, or compromised data integrity. With the growing complexity of clinical studies, especially in oncology, rare diseases, and personalized medicine, pharmacovigilance in trials must be proactive, integrated, and responsive to emerging risks. Effective clinical trial safety oversight sets the foundation for a therapy’s long-term benefit-risk evaluation.