Expanded Access Programs

An Expanded Access Program (EAP) allows physicians and patients access to pre-approval, investigational drugs outside of the clinical trial setting. 

EAPs allow sponsors to provide access to pre-approval products outside of clinical trials. These programs are unique in each country and require different levels of regulatory approval.  

These programs are for patients suffering from a serious or life-threatening illness who have no viable treatment options available to them. This means that:

How Sponsors Benefit

Under The 21st Century Cures Act, all companies with drugs in clinical trials that meet the criteria for expanded access must now have an Expanded Access Policy posted on their website.

If you have a product in, or reaching, late stage clinical development for cancer or rare diseases, now might be a good time for you to start thinking about expanded access and your company’s ability to handle potential patient requests.

21st Century Cures Act

An Expanded Access Program may also be called

Compassionate Use Program (CUP)

Early Access Program

Managed Access Program (MAP)

Post-Trial Access Program

Our EAP Services

If you are a sponsor with a product in development and you require the deployment of an EAP, or if you would like to discuss distribution of your drugs to manage requests from patients/physicians, please complete the form to the left or contact us at: