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Comply GDPR/FDA/EMA/GCP standards

ShareCRF complies with the demanding requirements of the LOPD, FDA, EMA y GCP.

ShareCRF complies with the following requirements:

FDA, EMA y GCP

Our electronic CRF complies with the highest requirements of data quality FDA 21 CFR Part 11, EU GMP Annex 11 and GCP E6 in everything related to clinical trials, allowing maximum security for your studies and clinical trials. ShareCRF provides the following functionalities to comply with the indicated regulations:

GDPR

The service of ShareCRF will help you to comply with the standards required by the General data Protection Regulation (UE 2016/679). Our service is prepared to treat as a treatment manager according to the General Data Protection Regulation.

Our server infrastructure uses AWS (Amazon Web Services) services and we operate in a shared environment of responsability with them with the aim to comply the rules of data protection set by the EU. You can find out more about compliance with the EU data protection regulation of AWS.