top of page
Modern Work Space
Getting Coffee
Business Meeting
Businesswoman in white
Business Conference
Business Meeting
Conversation Between Colleagues
Informative Interview
Standing Meeting
Casual Business Meeting

Our Purpose is your resource for demystifying the complex world of data protection while applying the nuances of the pharmaceutical industry.  Here at, we’ve seen it all – marketed products, investigational products, sponsors, CROs, labs, and other vendors, so we’re here to help you understand how GDPR and other international regulations affect your specific operations and how to most efficiently develop a compliance program tailored to your specific needs.

Concrete Wall

Top Privacy Compliance Risks


The biggest demonstrator of GDPR compliance is proper documentation.  This extends beyond your required policies, procedures, and privacy notices, but also to contracts  in place with vendors, clinical trial sites, and employees.  

How confident are you in your GDPR documentation?




Unlike other US-regulated activities,  GDPR responsibilities cannot be contractually transferred to vendors.  Controllers and processors are each independently responsible for their own data protection activities, but the controller ultimately remains responsible for ensuring the protection of personal data of its data subjects.  Do you have sufficient contracts in place with vendors regarding their responsibilities to protect personal data?  

How confident are you in their compliance?


Data Transfers

Any data transferred from the EU or UK to the US has to be subject to an approved mechanism of transfer (Article 46, GDPR).  Transfers include not just storage but viewing too.  If personal data is accessible in the US  such as clinical trial subject data in the EDC (even if pseudonymized), patient data, or physician data, you must have an

approved mechanism of transfer.  This is the most common reason US companies are in the news for GDPR non-compliance.  Do you know what your transfer mechanisms are to make your transfers legal?

Contact Us

Thanks for submitting!

bottom of page