Medable’s electronic trial tech approved by French data privacy regulators

French data privacy regulators have approved Medable’s electronic consent and clinical outcome assessment technologies in a decision the firm says will expand “access for digital clinical trials across the European Union.”

Medable announced the Commission Nationale de l’Informatique et des Libertés’ (CNIL) decision last week, revealing its eConsent and eCOA solutions have been granted for use in two clinical studies in eight countries outside of the EU.

The Palo Alto, California, trial technology firm cited its partnership with French drug manufacturer Servier as key, explaining the firms compiled validation documents, ran demonstrations and video training, and answered CNIL’s questions about data security.

Andrew Mackinnon, Medable executive general manager, told Clinical Insider, “The CNIL MR-001 reference document requires that any research conducted outside of its parameters — which in this case was the collection of identifiable and personal data to facilitate eConsent and email-based notifications and communication with the study participant — would need to receive a review and approval by the CNIL body.

He explained the process had involved a detailed assessment of the data security practices in place, as well as a review to confirm the collection of the information is necessary and offers a benefit to the participant.

“This reference guideline applies to all clinical research carried out in France, but also to all clinical research conducted by a French based company such as Servier. This approval demonstrates that Medable practices meet the strict criteria of CNIL,” he told us.

Business benefits

The CNIL decision is a vindication of Medable’s approach, according to Mackinnon, who predicted the firm would win more drug industry customers as a result.

“This approval shows that Medable not only has robust technical, security, and data protection capabilities but also the recognition that the collection of personal data provides a benefit to the study participants.

“This is also verification that we offer our partners the necessary expertise and partnership it takes for a complex approval process. We expect this will open the door to even more global business and further expansion on the adoption of eConsent,” he said.

Data privacy

Data protection has become a hot topic for sponsors and CROs working in the EU in recent years, primarily due to the adoption of the General Data Protection Regulation (GDPR) in 2016, which set requirements around the privacy of personal information.

In the years since, industry has sought to clarify the implications for drug trials. Recently, for example, the CNIL approved a GDPR Code of Conduct developed by trial services sector group European CROs Federation (EUCROF).

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