Clinical Data Management
Clinical Data Management
Personal data collected and processed during clinical studies are certainly among the most sensitive personal data.
Therefore, processes manipulating patient healthcare data are considered as critical per EU GDPR, and require a Data Protection Impact Analysis (DPIA) to be done, and a Data Protection Officer to be identified.
All our DPO associates have experience in clinical research and observational studies, and with data management.
We are familiar with ICH E6 guidances, with CFR 21 Part 11
and with Good Clinical Data Management Practices (GCDMP).
We have developped pre-filled examples of DPIAs and of records of processing, of ICFs and Investigator Notices dedicated to clinical studies: these templates accelerate the way we deliver ther services to your organisation, and guarantee we go directly to the point.
Feel free to contact us for a quote!