FDA and EMEA initiated safety-surveillance mandates have increased significantly in recent years and it is expected that nearly all products gaining regulatory approval will have at least one post-market commitment imposed.  

In addition, product developers are increasingly looking to safety-surveillance studies to proactively provide broad, critical data on their products’ safety and effectiveness profiles. With these data in hand, developers can better assess and communicate emerging risks and benefits associated with their products.

To meet these demands, our Drug Safety team brings Sponsors an unparalleled combination of global reach, technical expertise, and industry-leading experience in designing and implementing post-approval research programs.  Comprising resources of both our Drug Safety and Lifecycle Sciences groups, we offer expertise in designing, implementing, analysing, and reporting across a wide range of safety-study approaches:

• Mandated safety studies
• Large, simple trials
• Observational Safety Surveillance Registries
• Extended Duration Pharmacovigilance