Privacy and Data Protection Program for a Life Sciences Firm
A records-of-processing inventory and transfer framework that passed sponsor audits cleanly.
Client name withheld by agreement- Client
- Clinical research organization
- Region
- U.S. and EU
- Year
- 2023
- Duration
- 16 weeks
- Scope
- 14 countries · 220 processing activities
- Practice
- Offensive Security & Resilience
The challenge
What was at stake.
A clinical research organization processed patient data in fourteen countries for sponsors who audit relentlessly. Its privacy documentation lagged far behind its operations.
Sponsor audits were becoming a commercial risk, and cross-border transfers were the hardest question to answer.
What we did
The approach, step by step.
- 01
Records of processing
Two hundred and twenty processing activities inventoried, with purpose, legal basis and retention.
- 02
Transfer framework
Cross-border transfer mechanisms and assessments completed for every data flow out of the EU.
- 03
Privacy by design
Privacy impact assessments built into study start-up so new studies launch compliant.
- 04
Sponsor audit readiness
An evidence pack that answers the questions sponsors ask before they ask them.
Outcomes
What changed, in numbers.
- 220
- processing activities documented
- 14
- countries covered
- 100%
- of sponsor audits passed cleanly
- 1
- transfer framework for every EU data flow
Privacy went from our weakest audit topic to our strongest.
Services delivered
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