A strong quality assurance policy
to provide compliance and documentation
Je suis une CRO
PERSONAL DATA PROTECTION
ClinInfo uses a « privacy by default » and « privacy by design » approach, ensuring maximal protection of peronal data during all steps of your projet's lifecycle.
To help you with your administrative procedures, we provide documentation regarding our compliance with the General Data Protection Regulation (GDPR) as well as physical and digital security measures protecting our servers and applications.
CLINICAL TRIALS REGULATION
From our university origin, we have developed an efficient quality system adapted to any kind of reasearch project: interventional or non-interventional, medical device...
With 3 to 4 external audits per year as well as multiple internal audits, we check and improve our quality system to ensure with the best transparency compliance with numerous regulatory requirements: 21 CFR Part 11, GMP Annex 11, ICH GCP, GDPR...
VALIDATION OF COMPUTERIZED SYSTEMS
Each project that uses our solution follows a strong validation process based on GAMP 5 methodology. Our team provides a set of documents that rigorously proves the reliability of our digital applications and of your data processing.
This validation is based on a GxP risk analysis, which not only includes digital-related stakes, but also includes risks regarding personal data protection, security of treatments provided to patients or traceability of all actions performed.