Cohort Compassionate Use and Expanded Access
Early Access Care is the solution to pharmaceutical company compliance with the new legislation as it pertains to Expanded Access.
Expanded Access Programs (EAP) For Groups of Patients or Cohort Programs
A multi-patient Expanded Access Protocol (EAP) or cohort compassionate use protocol may be suggested by a health authority when there have been several individual expanded access requests and it is anticipated that additional requests are likely. EAPs are not clinical trials and do not advance drug development programs.
Our expertise is in the development, management and oversight of EAPs. We have sought the advice of the FDA and other health authorities in the development of EAPs and understand this area well. Let us develop the EAP for your program. We are experts in Expanded Access. We are here to help you.