Clinical Research IO’s Full 21 CFR Part 11 Attestation from Advarra (Formerly Kinetiq)

CRIO recently received attestation from Kinetiq (now Advarra) that our policies and procedures conform to the requirements of 21 CFR part 11 and Annex 11. Part 11 is the FDA’s requirement for use of electronic data in clinical trials, which is a part of Good Clinical Practice (GCP) and Good Documentation Practice (GDP). Annex 11 is widely viewed as the FDA equivalent in the European Union.  Download the full case study from Advarra here!

Clinical Research IO's 21 CFR Part 11 Compliance Assessment

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