Managed Access Programs
Conducting a Managed or Expanded Access Program (EAP/MAP), whether under a Treatment IND, Emergency Use Protocol, Compassionate Use or Named Patient Basis program, requires specialized strategies, skills and resources different than a conventional clinical trial to deliver life-saving treatments securely to patients with unmet medical need.
PAREXEL has the expertise, experience and infrastructure to help you navigate the complex regulatory and logistical issues of expanded access programs worldwide. Our approach utilizes cost effective, centralized management of Expanded Access Programs, combined with integrated drug supply and logistics and state-of-the-art technology, to support any program size or geographical reach.
Our Managed Access Program Service supports and adheres to our clients’ policies, and provides significant savings in costs and timelines through built-in efficiencies at both global and local levels. You can count on PAREXEL for a complete end-to-end solution, offering:
- Extensive experience in oncology, infectious disease, rare and orphan diseases and CNS
- An inclusive library of best practices and dedicated SOPs
- Specialized strategies, skills and resources, different from a conventional clinical trial, to deliver compassionate use through managed access
- Support in navigating complex regulatory and logistical issues worldwide
- Cost-effective, centralized management combined with integrated drug supply and logistics and state-of-the art technology
- Support for participating physicians and pharmacists while achieving program objectives
- Highly efficient, cost-effective systems and procedures to maximize ROI
For more information contact the Expanded Access services team.