Clinical Research & Data Protection
Senior international experience across clinical operations, regulatory affairs, quality, TMF, inspection readiness and data protection, in both sponsor and CRO environments.
Why Ethica
Data protection expertise grounded in clinical research
Senior expertise. Emerging perspectives.
Ethica brings together senior international experience in clinical research and data protection, complemented by expertise in AI, MedTech and legal aspects of informed consent.
We provide practical advice that you can apply within your existing operations.
A multidisciplinary perspective
Recognising the evolving landscape of life sciences and clinical research, Ethica was built around a multidisciplinary model, bringing together trusted specialists with long-standing professional relationships.
AI & MedTech
Practical experience in AI-driven medical devices and digital health, with a focus on data protection and the challenges of emerging healthcare technologies.
Legal & Informed Consent
Legal expertise and postgraduate specialisation in clinical research informed consent, with a focus on participant rights and transparency.
Meet the founder
The founder
Catalina Danila — Founder
Track record
- 25+ years in life sciences
- 20+ years in clinical research
- 6+ years specialising in data protection
- DPO experience across biotech, pharmaceutical and CRO organisations
- Senior international leadership experience in clinical research
- Former Chief Operating Officer in health technology
Catalina is a pharmacist by education, with more than 25 years of experience in life sciences and clinical research. She later specialised in GDPR and data protection, building on her extensive industry experience.
Catalina began her career in pharmacovigilance and quality with major pharmaceutical companies before moving into clinical research. She gained experience in clinical operations and regulatory affairs before moving into international leadership roles in TMF management at a leading CRO. Her interest in data protection grew out of the practical challenges of clinical research, particularly questions of responsibility and accountability between sponsors and CROs, and ultimately developed into a professional specialisation.
Catalina later became Chief Operating Officer of a health-tech start-up, where she was directly responsible for data protection. Working with external GDPR consultants, she realised that standardised approaches do not always suit smaller organisations handling sensitive health data.
These experiences shaped her view that data protection must be legally sound, but also proportionate to an organisation’s size, resources and operational needs. She founded Ethica on this principle, combining her clinical research experience with established GCP and quality management practices.
Today, Catalina acts as DPO and data protection adviser to biotechnology, pharmaceutical and CRO organisations, supporting both corporate operations and clinical research across multiple jurisdictions. Her work spans privacy strategy, governance, implementation and complex regulatory matters.
Practical approach
We evaluate and build on what you already have in place
In life sciences, many data protection requirements are already addressed through GCP-driven processes, quality systems and established operational controls.
We build on your existing controls, focusing on what is needed to meet GDPR requirements.
We don't create a parallel compliance layer. We make data protection work within your existing operations.
Discuss your privacy needs
Whether you need to strengthen your existing privacy framework, resolve a specific issue or clarify which requirements apply to your organisation, we can help you find the right approach.