Bioequivalence and Bioavailability Forum

Hello Tina,

❝ If a CRO has clinical facility in house but outsources hematology and biochemistry analysis and bioanalytical laboratory, what accreditations should a sponsor review for the laboratories for considering CRO for selection to a study?

To the best of my knowledge many countries do not require accreditation, but they do require that some quality standards be observed, most often GLP (e.g. EU, WHO and more). Oftentimes CROs have accreditation under ISO 9001, ISO 17025 (the bioanalytical part) or ISO 15189 (the hematology part) without this being a regulatory requirement.
Very often some degree of common sense is more important than a certificate. I guess my recommendation would be to select your supplier on basis of any mandatory quality standard, otherwise on basis of common sense. Consequently I would not select a supplier solely on basis of a quality standard that isn't mandatory from the regulatory perspective, on basis of the number of accrediations they have or the number of regulatory inspections they have hosted.