Early Access Care is the solution to pharmaceutical company compliance with the new legislation as it pertains to Expanded Access.
Establishing an EAP & CUP
An EAP or CUP may be planned in parallel to clinical development, or may be suggested by a health authority.
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 or CUP for your program. We are experts in EAPs and CUPs. We are here to help you.