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Phase IV

PAREXEL PACE Group has significant experience in the implementation and management of Phase IV trials which include the successful implementation of some of the largest trials of marketed products ever conducted. This operational expertise, coupled with PAREXEL's ability to provide integrated service offerings such as technology solutions that streamline the operations of trials conducted in the Phase IV arena, positions PAREXEL as the CRO of choice.

Within the past three years, PAREXEL has been involved in over 220 Phase IV trials conducted at sites around the globe. Collectively, these studies have involved the enrollment of over 330,000 patients across approximately 29,000 sites located across the globe.

As a result of this experience, PAREXEL is keenly aware of the challenges faced with managing large studies involving various types of investigative sites. This has allowed us to develop procedures specifically designed to effectively recruit, initiate, and manage these sites, as well as a keen understanding of late phase issues including:

  • The complexity of stakeholder objectives: R&D vs. Marketing; Central vs. Local Marketing Companies; Opinion Leaders vs. Practicing Physicians
  • The need to support both R&D and commercialization: rigorous studies with sound scientific/medical rationale providing good publishable data
  • The importance of timing relative to product launch or other key event: expediting study timelines with variable start / finish by country
  • The diversity in regulatory requirements: liaison with local regulatory authorities and knowledge of all applicable laws and guidelines for investigational drugs or marketed products
  • The critical care of sites: sensitive site management in harmony with the characteristics and expectations of end-users

For more information, please contact the PACE Group.