CliniSafe operates within the regulated pharmaceutical industry, and takes these obligations seriously.
CliniSafe operates in compliance with FDA 21 CFR part 11. This ensures that data within the system is not able to be corrupted, is secure, can be verified via audit trail and is accountable to individuals.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US.
CliniSafe promotes ethical and safe clinical practice and data integrity according to ICH GCP guidelines, incorporated in UK Statutory Instrument 1004 no 1031.
CliniSafe follows the 8 principles of the UK Data Protection Act 1990.