Pharmacovigilance services

We offer pharmacovigilance services including SUSAR reporting, medical monitoring, and coding of adverse events, medical history and prior/concomitant medications.

Monitoring drug safety

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 also 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