AI Clinical Research
AI is transforming clinical research from drug discovery through trial design to post-market surveillance. We ensure your AI-driven research complies with the EU AI Act, GDPR, MDR/IVDR, and GCP standards throughout the development and deployment lifecycle.
AI Applications in Clinical Research
We help life sciences organisations deploy AI responsibly across the clinical research lifecycle, from drug discovery through post-market surveillance. Our expertise spans the intersection of the EU AI Act, GDPR, and sector-specific requirements, ensuring your AI applications meet regulatory expectations while accelerating innovation. Whether you're using AI for molecular analysis, trial optimisation, regulatory submissions, or pharmacovigilance, we provide the governance frameworks, documentation, and validation support you need to deploy with confidence.
AI accelerates drug discovery through molecularanalysis, target identification, and compound optimisation. These applications must meet ethical data sourcing requirements, model transparency standards, and documentation obligations under the EU AI Act.
AI enables trial optimisation adaptive designs, patient recruitment, protocol development, and site selection. AI systems influencing trial design or patient safety require appropriate risk management and human oversight.
AI-related regulatory submissions require specialised documentation demonstrating compliance with applicable requirements. This includes algorithm descriptions, validation reports, and explanations suitable for regulatory review.
AI powers clinical data management, automated cleaning, query resolution, and sophisticated analytics. AI in the data pipeline requires governance, validation, and audit trails ensuring data integrity.
AI-related regulatory submissions require specialised documentation demonstrating compliance with applicable requirements. This includes algorithm descriptions, validation reports, and explanations suitable for regulatory review.
AI in post-market surveillance and pharmacovigilance, adverse event detection, signal identification, and benefit-risk assessment, must meet both the EU AI Act and the sector-specific pharmacovigilance requirements.
How iliomad Health Data Can Help You
AI systems in clinical research process sensitive personal data, triggering both AI Act and GDPR requirements. Privacy by design must be integrated throughout AI development and deployment.
FAQs
Our frequently questions
AI applications in drug discovery, trial optimization, regulatory submissions, and pharmacovigilance must comply with EU AI Act, GDPR, MDR/IVDR, and GCP standards simultaneously. We provide integrated AI regulatory, data protection, and cybersecurity compliance across all AI applications in clinical research, with experience in 66 countries.
Critical risks include drug discovery AI lacking validation documentation, trial optimization algorithms without EU AI Act conformity assessment, AI-generated evidence lacking transparency for regulatory submissions, patient data processing without proper GDPR legal bases, and pharmacovigilance AI making safety decisions without human oversight. These trigger regulatory rejections, authority investigations, and can invalidate AI-generated evidence.
We provide AI regulatory compliance (conformity assessment, algorithm validation, regulatory submission documentation), data protection compliance (privacy integration, patient data governance, consent frameworks), and cybersecurity compliance (AI system security, adversarial protection, model integrity). Our services cover drug discovery AI, clinical trial optimization, regulatory submissions, data management, and pharmacovigilance applications.
No - it depends on risk classification: drug discovery AI analyzing molecules is typically limited-risk (transparency only), trial optimization AI for patient selection is often high-risk (conformity assessment required), and AI medical devices in trials need full MDR/IVDR + EU AI Act compliance. We assess your AI systems and implement proportionate compliance based on actual risk level.
Contact us through our website form or email directly. We'll schedule an initial consultation to understand your regulatory landscape, identify immediate priorities, and propose a tailored engagement that fits your timeline and budget.
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