Early access programs

ClinSearch has been supporting the pharmaceutical industry for more than 10 years in the implementation and monitoring of compassionate use and early access programs (EAPs). Since the reform on July 1st, 2021 in France, we have implemented compassionate access (AAC), pre-AMM (AP1), and post-AMM (AP2) early access on behalf of our clients, with thousands of participants accessing treatment via our platforms. We've had the pleasure of collaborating with French governmental agencies on pilot programs related to EAPs. Our solutions are highly regarded by healthcare professionals throughout France for their excellence.

In addition to our ISO27001 and ISO9001:2015 certifications, ClinSearch is proud to be certified in Health Data Hosting (HDS). We work only with HDS-certified hosting companies located in France. Together, our HDS certification and HDS collaborations ensure that our Early Access program is fully compliant with French local regulations, particularly, CNIL regulations RS–003 and RS–004.

Our multidisciplinary team has outstanding experience managing these programs, and as such is able to work within tight deadlines. Given our experience and in-house development of the access program platforms, without relying on third party suppliers to build or customise them, we support, for example, programs that transition from a Compassionate Use to an Early Access (pre-AMM, or AP1) to a post-AMM or AP2, in a seamless manner. We offer the necessary flexibility to adapt the program as required, whether following a client request or in response to the ever-changing regulatory landscape.