DPO for Clinical Trials & Life Sciences

Data Protection Officer for Clinical Trials & Life Sciences

Outsourced Data Protection Officer for sponsors and CROs

Ensure compliant, confident clinical research with a DPO who understands the realities of study operations. We provide Life Sciences sponsors and CROs with sector-specific DPO leadership-covering governance, DPIAs, participant rights, vendor oversight, and alignment with EU frameworks-so your studies run securely and efficiently across Europe and beyond.

Why a DPO matters in clinical research

Clinical trials involve large-scale processing of special-category data and complex chains of processors and sub-processors. A DPO for Clinical Trials gives you an independent, expert voice embedded in decision-making-protecting participant trust, reducing regulatory exposure, and enabling study delivery on time.

Your DPO will:

• Advise on lawful bases and purpose limitation for protocol activities.
• Embed privacy-by-design into systems (EDC, CTMS, eTMF, eConsent, ePRO, wearables, imaging, genomics).
• Define clear responsibilities across Sponsor/CRO/Sites and vendors.
• Monitor compliance and report to leadership with actionable KPIs.
• Coordinate responses to data subject requests without compromising scientific integrity.

Our DPO services for Clinical Trials & Life Sciences

DPO as a Service (DPOaaS). A named DPO Life Sciences professional integrated with your team, providing strategic guidance and hands-on support throughout the study lifecycle.

Protocol & country readiness. Data flow mapping, records of processing activities, controller/processor qualification (Art. 26/28), and contract annexes tailored to local requirements.

DPIA leadership. Methodology, challenge sessions, and recommendations for high-risk processing-including digital endpoints, remote monitoring, and cross-border data transfers.

Participant transparency & rights. Multilingual participant information, standardized workflows for access/erasure/restriction, and a central log with turnaround SLAs and audit trail.

Security & vendors. Technical and organizational measures review, vendor due diligence, DPA clauses, Sub-processor governance, and operational checks for ongoing assurance.

Training & awareness. Role-based sessions for clinical teams, sites, and vendors to drive consistent, audit-ready behaviours.

Alignment with the EUCROF CRO Code of Conduct

For organisations operating in the CRO ecosystem, we help assess gaps and implement pragmatic controls aligned with the EUCROF sector framework-so your DPO Clinical Research oversight is anchored in recognised best practice.

Non-EU sponsors: EU Data Protection Representative (DPR)

Running EU studies without an EU establishment? We can provide the EU Data Protection Representative alongside your DPO, ensuring an effective point of contact for supervisory authorities and data subjects, and smooth communications throughout the study.

How we work

Discovery & plan. We review your portfolio, systems, vendors, and countries to prioritise risks and opportunities.
Embed & govern. Your DPO attends key governance forums, reviews protocol changes, and tracks KPIs.
Measure & improve. Regular reports, audit-ready documentation, and continuous optimisation.

What makes us different

• Clinical operations fluency. We understand real study workflows-from start-up to close-out-so our guidance is practical, not theoretical.
• Scalable across countries. Multilingual specialists support harmonised practices while respecting national specifics.
• Proof, not promises. Clear registers, decisions, and evidence designed for internal audit and authority review.

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