Iliomad

Compliance solutions meticulously designed to align life sciences organizations with the UK Data Protection Act 2018 and UK GDPR framework, supporting clinical trials, AI development, and healthtech innovation.

Compliance support and governance frameworks for AI-driven drug discovery, molecular analysis, target identification, and compound optimisation under the EU AI Act and GDPR.

Authorized representative services for non-EU organizations placing AI systems within the European market to ensure continuous compliance with EU AI Act obligations.

Data governance and protection services for AI in genomics and personalized medicine.

Consulting and advisory services designed to help life sciences companies master data usage, control, legal basis for collection and reuse, and data transfer frameworks.

Regulatory and compliance consulting for AI-enabled clinical trial optimisation, adaptive designs, patient recruitment, protocol development, and site selection.

Comprehensive integration services harmonizing cybersecurity with data protection, quality management, and AI regulatory requirements.

Comprehensive services for upholding clinical trial compliance with stringent privacy regulations, including risk analysis, data protection impact assessments, ICF & CTA reviews, and DPO services.

Official EU Data Protection Representative services fulfilling GDPR Article 27 requirements for non-EEA organizations, including authority liaison, DSAR management, and compliance support.

Contractual review services leveraging extensive life science industry experience to help parties abide by the GDPR.

External DPO services to establish your company's compliance system for medical research operations.

Consulting and compliance services for health data warehouses and platforms, consolidating clinical, operational, and research data under regulatory frameworks like GDPR, HIPAA, and French HDS.

Specialised Data Protection Officer services for clinical research overseeing compliance with GDPR, HIPAA, FADP, and regional frameworks.

Governance, validation, and audit trail implementation for AI-powered clinical data management, automated cleaning, query resolution, and analytics.

Acting as your designated European Data Representative under Article 27 of the GDPR, serving as the primary point of contact for data protection supervisory authorities and data subjects.

Compliance services for AI in telehealth, chatbots, and remote monitoring.

Bespoke and adaptable GDPR Quality Assurance (QA) system specifically designed for life sciences companies.

Compliance services for AI usage in post-market surveillance and pharmacovigilance, adverse event detection, signal identification, and benefit-risk assessment.

Data Protection Impact Assessments tailored for high-risk processing activities typical in clinical trials.

Support and coordination for interactions with ethics committees, competent authorities, and data protection supervisory bodies.

Compliance management and security assessments for third-party clinical trial vendors and partners.

Thoroughly addressing privacy-related requirements and developing remediation plans for privacy shortcomings to support financing rounds.

Consulting and support services to establish health data warehouses, covering project structuring, regulatory approvals, data governance, risk analysis, and data protection impact assessments.

Documentation and compliance services for AI in robotic surgery.

Robust security architectures, API security, identity management, and access controls for HealthTech platforms processing patient data at scale.

Expertise in conducting DPIAs for medical research utilizing unique templates and methodology.

Review and development of Informed Consent Forms and clinical trial agreements to satisfy ethical and privacy requirements.

Comprehensive gap analysis services comparing client operations against global privacy regulations including UK GDPR, HIPAA, PIPEDA, and PIPL.

Embedding privacy by design principles throughout device development from initial concept through design, manufacturing, and post-market activities.

Mandatory GDPR training for all personnel involved in processing EU personal data.

Implementation support for AI-powered Clinical Decision Support (CDS) integrated into EHRs and clinical workflows.

Comprehensive lifecycle support and consulting services ensuring connected medical devices comply with EU MDR, IVDR, FDA regulations, and data protection requirements.

Reviewing and optimizing Informed Consent Forms where privacy is at the center of clinical trials.

Specialized data protection and compliance guidance for In Vitro Diagnostics, genetic testing, and companion diagnostics processing sensitive information.

Creation and revision of privacy-relevant study documentation including protocols and data management plans.

Compliance consulting for health and medical apps to navigate regulatory classifications, privacy requirements, and secure data handling across platforms.

Defense-in-depth cybersecurity strategies and compliance frameworks tailored to clinical environments and hospital networks.

Assistance in establishing clinical data hosting strategies compliant with regulations.

Security architectures and regulatory guidance for telehealth, remote patient monitoring, and digital therapeutics platforms.

Cybersecurity compliance services covering MDR/IVDR Annex I, IEC 62443, and FDA guidance for connected medical devices.