ETHICA Compliance

Data Protection & DPO Services

We offer specialist data protection advisory and external DPO services, combining GDPR expertise with a practical understanding of clinical research and life sciences.

We help you manage GDPR compliance throughout the clinical trial lifecycle, from defining responsibilities and assessing risks to overseeing vendors and international data transfers, while building on your existing governance and quality systems.

DPO Oversight & GDPR Governance

  • External DPO appointment, independent oversight and compliance monitoring
  • GDPR advisory, accountability frameworks and gap analyses
  • Policies, SOPs, Records of Processing Activities (ROPA) and compliance documentation
  • Data Protection Impact Assessments (DPIAs) and privacy risk assessments
  • Controller, processor and subprocessor roles and responsibilities
  • Vendor privacy due diligence, Data Processing Agreements (DPAs) and assessment of technical and organisational measures
  • International data transfers, SCCs, UK transfer mechanisms and Transfer Impact Assessments (TIAs)
  • Data subject rights, personal data breaches and regulatory interactions
  • Privacy by Design, AI governance and compliance remediation
  • Support during audits and inspections

Clinical Research Data Protection

  • Study-specific privacy strategy, GDPR gap analyses and risk assessments
  • Controller and processor role analysis, data flows and processing activities across the study lifecycle
  • Review of informed consent forms (ICFs), participant-facing privacy information and study privacy notices
  • Review of protocols, clinical trial agreements and related study documents to ensure consistent data protection provisions.
  • Assessment of country-specific data protection requirements and local authority or ethics committee expectations
  • CRO and study vendor privacy assessments, contractual arrangements and international data transfers
  • Privacy assessment of clinical trial systems and technologies
  • Assessment of protocol amendments, changes to vendors, systems and data flows
  • Data subject rights and personal data breaches in the clinical trial context
  • Data protection support during study conduct, audits and inspections

Employee & Workplace Privacy

  • Employee and candidate privacy
  • HR data processing activities
  • Workplace technologies and employee monitoring
  • Remote and home-working privacy

Discuss your data protection needs

Whether you need corporate privacy support, help with a specific project or specialist input on a complex data protection matter, we can discuss the approach that fits your organisation.

Not sure which data protection or privacy requirements apply to your activities?