Early / Compassionate Use


You wish to implement an ATU* ou une RTU*, RCTs’ experts will guide and advise you on the regulatory process, the drafting of study documents, the organization of logistics, the management of pharmacovigilance, the data management via a digital solution dedicated to the specificities of these studies, the data analysis or study reports writing for the ANSM.

*The Temporary Use Authorisation (ATU) allows patients to benefit from pharmaceutical products when they do not have a marketing authorization, provided they are intended for the treatment of serious illnesses or rare diseases and if appropriate treatment doesn’t exist.

*The Temporary Use Recommendation (RTU) makes it possible to regulate prescriptions that do not comply with the marketing authorisation (MA), provided that there is an unmet therapeutic need, and that the benefit / risk ratio of the medicinal product is expected to be favourable, in particular if based on published scientific data on efficacy and tolerance

We have already accompanied them

Early access and real word data: the example of the DARATUMUMAB cohort ATU

Our experts are available for you

Study Director - Member of the AFCROs MD working group

Next expertise

Pre-Authorization Studies Learn more

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