Early access programs
EAPs and Compassionate programs deserve the attention of highly qualified professionals who appreciate the significance of these programs and understand the urgency these programs require.
Euromed is set up to support the industry, ensuring access for the patients to medicines from their very early stages of clinical development, through Ph-II, Ph-III or even if the product was just approved in a country but not yet in another.
Our objective is to ensure that you, as the Sponsor, have the time to focus on the advancement of your drug product. while will take on not just the management and distribution of these programs, but all the various activities related to it.
WHAT WE DO
Pre-Approval Access Managed Access
Early access programs (EAPs) are being used by an increasing number of pharma companies to ensure access to therapies also for patients from serious life-threatening or rare diseases that cannot take part in a clinical trial or have no treatment options available. These patients can be supported by EAP programs and request the right for individual access to life-saving treatments (Named Patient Programs).
These EAPs are also implemented when the drug is approved in one country but not in another country where it is needed and requested by terminally ill patients. Given the fast pace with which some treatments for life-threatening diseases are advancing, the industry is counting more than ever on organizations who can support them in making sure that through their EAPs they can offer ethical, compliant, and controlled mechanisms to provide access to investigational drugs outside of their clinical trials and or countries where the product may not be registered yet.
EAPa programs are often referred to by many different names, including Managed Access, Pre-Approval Access, Expanded Access and Compassionate Use
Whatever case applies, Euromed can help manufacturers to liaise with targeted specialized physicians and identify specific national reimbursement strategies in order to reduce the distance between the unlicensed medicine and patient.