Description

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), or accès dérogatoires; accès compassionnel et accès précoce. Since the reform of 1 July 2021, 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 had the pleasure of working with French governmental agencies on pilot programs related to EAPs, and are recognised by healthcare professionals across France as providing an outstanding solution.

ClinSearch is proud to be HDS (hébergeur de données de santé) certified (along with ISO27001 and ISO9001:2015 certified). As well as working with HDS-certified hosting companies located in France, ClinSearch itself undertook this certification ensuring that the whole early access program is fully compliant with the local regulations in France, in particular in regards to the 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.

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Reach out to:
business-development@clinsearch.net