Peri-Approval & Observational Research

Case Study

A large, multinational pharmaceutical company needed to complete a Phase 3b/4 study to assess the efficacy and safety of its new oral treatment for rheumatoid arthritis. With ICON’s dedicated late phase experts, enrolment simulation models, and feasibility expertise, the client was able to surpass their original enrolment deadlines. 

Peri-Approval and Observational studies are used to generate real world evidence, address questions pertaining to disease states and treatment patterns, provide early access to therapies, 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
  • Expanded Access, Named Patient Programs and Compassionate Use
  • Non-interventional, Observational Research

Our experts  also provide Safety Surveillance and Risk Evaluation Mitigation Strategies (REMS) to help you develop the best strategies that minimise risk and maximise benefit at the outset.