Global Privacy Program for a Clinical Research Organization
Participant data from 140 trials governed under one privacy program, with transfer assessments that sponsors and EU ethics committees accepted.
Client name withheld by agreement- Client
- Clinical research organization, trials in 22 countries
- Region
- Bridgewater, New Jersey and Frankfurt, Germany
- Year
- 2023
- Duration
- 16 weeks
- Scope
- 140 active trials · 22 countries · GDPR, HIPAA and U.S. state health-data laws
- Practice
- Offensive Security & Resilience
The challenge
What was at stake.
A clinical research organization runs trials for pharmaceutical and biotech sponsors in 22 countries, collecting participant health, genetic and device data through investigator sites, eConsent tools and wearable sensors.
Sponsors had started auditing its privacy controls directly, the EU-U.S. Data Privacy Framework had changed the transfer picture, and new U.S. state health-data laws reached data the company had treated as outside HIPAA. Each regional office answered these questions differently.
What we did
The approach, step by step.
- 01
Data inventoried by trial
We mapped participant data across 140 active trials, from site entry and eConsent to labs, wearables, analytics and sponsor delivery, recording the legal basis for each flow.
- 02
Transfers documented once
Transfer impact assessments, standard contractual clauses and Data Privacy Framework reliance were set out per data flow, so a new trial reuses an approved pattern.
- 03
Pseudonymization standardized
Participant coding, key custody and re-identification controls were made consistent across regions and written into the trial startup checklist.
- 04
Privacy by design at protocol stage
A privacy review now runs during protocol design, removing unnecessary data collection before sites are trained.
Outcomes
What changed, in numbers.
- 140
- active trials under one program
- 22
- countries with documented transfer assessments
- 31%
- fewer data elements collected in new protocols
- 0
- major findings in sponsor privacy audits
Sponsors now audit us and leave with fewer questions than they arrived with.
Services delivered
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