Expanded 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.
Managing expanded access programs on a domestic or global scale requires highly efficient, cost-effective systems and procedures to maximize investment return. Moreover, efficiently supporting participating physicians and pharmacists needs, while achieving the program objectives, is a key measure of success for any expanded access program.
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.
From conception to implementation, the Expanded Access Services team can provide the knowledge necessary for supporting key decisions on:
- The regional differences in regulatory systems and medical practice
- What constitutes "demonstration of unmet medical need"
- Consultation on the level of site management rigor needed for an Expanded Access Program
- Insights into benefits/risks in each local country set-up, including potential cost recovery
- Objective projections of physician interest, potential patient numbers and drug distribution
- Support of pricing strategies where appropriate
- Development of switch strategies for transitioning patient from clinical trial to commercial product
PAREXEL has been instrumental in successfully executing EAPs in a broad range of indications throughout North America, Europe, and the Asia Pacific region. Over the last five years, we have supported over 56 expanded access programs across the globe.
The Expanded Access services team can be a true partner in successfully fulfilling your strategic and operational goals in the conduct of Expanded Access, Managed Access and similar type programs.
For more information contact the Expanded Access services team.