Clinical Trials

Clinical trial sponsors must ensure that the processing of personal data from patients and healthcare personnel is compliant with data protection regulations. This includes obtaining informed consent from patients, implementing appropriate technical and organizational measures to protect personal data, and ensuring that data is processed only for the purposes for which it was collected. Data protection and data privacy can be complex to comply with, as many regulations may apply depending where the patients are enrolled and where the data are transferred.

Many regulations such as the GDPR, UK GDPR, Swiss FADP or HIPAA command that clinical trials sponsors comply with the privacy requirements under penalty of fine.

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How can iliomad Health Data help you ?

iliomad Health Data stands as a specialist in upholding clinical trial compliance with stringent privacy regulations, particularly as they pertain to clinical research and diverse research studies. With a track record of supporting over 30 clients spanning Europe, the US,  and Asia, our depth of expertise in fields from oncology to interventional studies is unparalleled. This allows our clients to fast-track their clinical programs, from phase 1 through to phase 3, introducing new drugs and therapies with reduced operational risks.

Our comprehensive services not only include crafting a robust privacy compliance program but also involve actively liaising with clinical sites, investigators, and regulatory authorities. Whether it's observational studies or more complex interventional clinical studies, iliomad Health Data remains hands-on. We are always ready with the right questions to ask and the correct answer to implement, ensuring steadfast support and guidance every step of the way.

Data Protection Officer or equivalent
ICF & CTA reviews
Carrying out a risk analysis (data protection impact assessment)
Gap analysis for multi centric studies
Vendor assesment and contractual reviews