Outsourcing in Clinical Trials Handbook Resource Centre


Thank you for coming to the PharMarketing OCT Resource page! If you've scanned our QR code from the OCT Handbook or webpage, you may be interested in more information regarding the General Data Protection Regulation, or GDPR, for running clinical trials in Europe. Our senior-level team at PharMarketing, which includes over 30 GDPR experts spread across Europe, supports companies with data privacy and compliance consultancy, audits and assessments, legal representation including Data Protection Officer (DPO) and Data Protection Representative (DPR) as well as drafting the policies and documentation required by GDPR.


GDPR is a European Union law that governs how personal and sensitive data is processed, and the European Economica Area (EEA), United Kingdom and Switzerland mirror GDPR in their privacy laws as well. The penalty for non-compliance is up to 4% of annual turnover, not to mention the loss of brand reputation and trust.


And, while it all sounds complicated, GDPR compliance is actually quite simple. Companies that are already compliant with Good Clinical Practices (GCP) are around 99% compliant with GDPR. PharMarketing closes that 1% gap so your trials are compliant.



1 in 3 inspections finds gaps in cross-border trials, according to data from the European Medicines Agency.


Clinical trials involve health data, which is explicitly listed in GDPR as related to vulnerable persons requiring strong protection of sensitive data; violations involving such data tend to trigger serious scrutiny.


For clinical research involving special categories like health data, GDPR requires explicit consent as a legal basis, which demands an unmistakable statement.​


Request our free eBook guide on managing GDPR for clinical trials in Europe!

Request our free eBook

REQUEST A FREE GDPR ASSESSMENT!


Planning on running clinical trials in Europe?

Schedule a call with one of our GDPR expert consultants to get a free assessment of where you stand when it comes to GDPR compliance and what services you may need to run trials in the EU, EEA, UK and Switzerland.

Schedule a free GDPR Assessment Call