Clinical Trials
Clinical trial sponsors, Contract Research Organisations, and research institutions face extraordinary complexity in ensuring that personal data from patients, investigators, and healthcare personnel is processed in full compliance with applicable data protection regulations. This challenge encompasses obtaining valid informed consent, implementing robust safeguards, ensuring lawful processing, and managing the data lifecycle from collection through retention. The complexity multiplies when trials span multiple jurisdictions - EU GDPR, UK GDPR, Swiss FADP, US HIPAA, and national frameworks each impose specific requirements. At iliomad Health Data, we help you navigate this intricate regulatory landscape with confidence.
Clinical Trial Compliance Requirements
Clinical trial data protection requires specialized expertise spanning multiple regulatory frameworks, jurisdictions, and stakeholder relationships. We ensure your studies remain compliant, efficient, and audit-ready from Phase I through Phase IV and beyond.
Clinical trials processing health data on a large scale trigger mandatory DPO appointment requirements under GDPR. Your DPO must oversee compliance with GDPR, HIPAA, FADP, and regional frameworks, ensuring alignment among sponsors, CROs, investigators, and other parties. A specialised DPO with clinical research expertise understands the practical realities of trial operations and can provide immediately actionable guidance.
Informed Consent Forms must satisfy both ethical and privacy requirements clearly explaining how participant data will be collected, used, shared, and protected throughout the study and beyond. Privacy notices must be accurate, comprehensive, and accessible, ensuring participants can make genuinely informed decisions about their participation.
Privacy-relevant study documentation including protocols, data management plans, vendor agreements, and site contracts must reflect current legal and ethical standards. Documentation should address pseudonymisation approaches, source data verification, monitoring access, safety reporting, and long-term retention requirements.
Clinical trial sponsors must navigate interactions with multiple regulatory authorities including ethics committees, competent authorities, and data protection supervisory bodies. This includes CTIS submissions in the EU, coordination with EMA and FDA, and responding to authority inquiries about data protection practices.
DPIAs are required for high-risk processing activities typical in clinical trials including processing of sensitive health data, systematic monitoring of participants, and large-scale data collection.DPIAs must be conducted before processing begins and updated as studies evolve.
Clinical trials involve complex vendor ecosystems CROs, laboratories, imaging centers, EDC platforms, IRT providers all processing personal data on your behalf. Each vendor relationship requires appropriate contracts, security assessments, and ongoing compliance monitoring.
How Iliomad Health Data Can Help You
iliomad Health Data specialises in privacy and data protection for clinical research, with a proven track record supporting over 30 life sciences clients across Europe, North America, and Asia. Our multidisciplinary team combines regulatory, operational, and technical knowledge to support sponsors and CROs from study design through post-marketing follow-up. Whether your project involves a decentralised clinical trial, anAI-driven healthtech study, or a multi-country Phase III program, we ensure data integrity, compliance, and operational agility go hand in hand.
FAQs
Our frequently questions
Clinical trials involve patient health data processed across multiple jurisdictions (sponsors, CROs, sites, regulators) under overlapping frameworks including GDPR, HIPAA, Swiss FADP, ICH-GCP, EU AI Act (for AI-enabled trials), MDR/IVDR (for device trials), and cybersecurity requirements (NIS2, ISO 27001) creating unprecedented regulatory complexity. With compliance experience across 66 countries, we provide integrated data protection, AI compliance, and cybersecurity services specifically designed for the clinical research environment from Phase I through post-marketing surveillance.
The highest-impact risks include inadequate informed consent forms with contradictory data sharing language, non-compliant cross-border data transfers lacking proper legal mechanisms (SCCs), AI systems in trials (patient selection algorithms, adaptive designs, investigational AI devices) without EU AI Act conformity assessment, cybersecurity vulnerabilities at investigator sites or in eCRF systems that compromise data integrity, and insufficient vendor due diligence for CROs, central labs, and data processors. These issues trigger ethics committee rejections, regulatory delays, authority investigations, and in severe cases can invalidate trial data or halt patient enrollment.
We provide dedicated clinical research DPO services, ICF/CTA review and development, cross-border transfer mechanisms, Data Protection Impact Assessments, AI system classification and conformity assessment for trial algorithms and investigational AI devices, AI governance frameworks integrated with GCP requirements, clinical research cybersecurity assessments, eCRF/EDC system security review, investigator site security protocols, vendor and CRO compliance management, incident response planning, and regulatory authority interactions for data protection, AI, and cybersecurity matters. Our integrated approach ensures coordinated compliance across all domains with unified documentation, eliminating gaps and contradictions that plague fragmented vendor relationships.
Any trial using AI requires compliance consideration—whether for investigational AI medical devices (requiring full EU AI Act + MDR/IVDR compliance), patient selection or stratification algorithms (potentially high-risk AI under EU AI Act), adaptive trial designs with AI-driven decision-making, AI analysis of imaging/biomarkers/genomics, or safety monitoring with predictive models. We assess your AI systems' regulatory classification, determine applicable requirements (EU AI Act, MDR/IVDR, ethics committee expectations), and implement proportionate compliance frameworks that don't over-engineer low-risk applications while ensuring high-risk AI meets full conformity assessment obligations.
Contact us through this page and we'll conduct a confidential assessment of your trial portfolio across data protection, AI, and cybersecurity domains, identifying immediate compliance priorities (upcoming study starts, ethics submissions, authority inquiries, vendor gaps). Within 2-3 weeks, we deliver a prioritized compliance roadmap with tailored service recommendations whether dedicated clinical research DPO, project-based ICF review, AI conformity assessment, cybersecurity framework implementation, or comprehensive integrated support—with transparent pricing and timelines aligned to your clinical development program and regulatory deadlines.
Any Questions ?
