Pharmacovigilance, or drug safety, is crucial to understanding a drug, biologic or combination product’s risk-benefit profile and protecting the welfare of patients by systematically detecting and assessing adverse events. We offer pharmacovigilance services including SUSAR reporting, medical monitoring, and coding of adverse events, medical history and prior/concomitant medications.
Pharmacovigilance is the study of detecting, assessing, and understanding adverse effects to monitor the safety of medicines. Drug safety monitoring is performed during clinical studies and we can support you with medical monitoring, SAE reporting, and SUSAR reporting to the regulatory authorities. In addition, pharmacovigilance is an important part of the product’s entire lifecycle and we also support sponsors with routine safety reporting to the authorities (DSURs/PSURs).
Medical monitors work closely with the sponsor and sites to perform qualified medical reviews of, for example, SAEs/SUSARs as well as providing general oversight and immediate support when safety issues arise. We understand that when it comes to safety, what we do is as important as how we do it, and in addition to regulatory compliance, we believe that clear communication, efficient reporting procedures, and seamless collaboration are essential for success.
Pharmacovigilance services may include:
- Safety reporting, including SUSARs, DSURs/PSURs, and patient safety narratives.
- Medical monitoring, including medical review of clinical data and consultation with medical monitors.
- Coding of adverse events, medical history and prior/concomitant medications.
