Peri-Approval & Observational Research

Peri-Approval and Observational studies can be used to address questions pertaining to safety surveillance, risk management and efficacy. Correct study choice and effective execution are paramount to achieving the desired goals.

ICON Commercialisation & Outcomes is experienced in the design and implementation of these studies to collect real-world data with a focus on maximising the return on investment.  These include:
  • Disease, Product Registries and Exposure Registries
  • Global Phase IIIB and IV Clinical Trials
  • Non-interventional, Observational Research
Our experts can also provide Safety Surveillance and Risk Evaluation Mitigation Strategies (REMS)  to help you develop the best strategies that minimise risk and maximse benefit at the outset.