The General Data Protection Regulation 2016/679 (GDPR) has come into force on May 25th, 2018. This new European regulation intends to empower and protect the data privacy of all EU natural persons and to reshape the way organizations are working with personal data. Such regulation has profound consequences on the planning and conduct of clinical trials. Understanding whether and how GDPR impacts your clinical trial is pivotal for the protection of patients and their personal data, as well as the data of all other individuals involved in the clinical trial. Non-compliance to GDPR may result in substantial fines (up to 4 % of annual worldwide turnover) as well as being detrimental to the clinical development per se.
VCLS’ data protection team, through its unique expertise in data privacy applied to medical research, accompanies HealthTech actors to gain proficiency in data privacy as well as building a robust compliance system that will enhance and secure their clinical trial.
GDPR services include:
- Training of management and clinical operation teams
- Clinical Trial mandatory documentation review (ICF, Protocol, etc.)
- Data Mapping (Organisational, Technical and Legal)
- Data Protection Impact Assessment (DPIA) required by GDPR
- Mandatory Documentation (SOP, MOP, Data privacy policies, Data Breach notification forms, etc.)
- Ad hoc Regulatory support
- Data Protection Officer (DPO)
- Data Protection Representative (DPR)
To learn more about VCLS’ resources regarding GDPR and Data Privacy please visit our affiliate iliomad: www.iliomad.fr