CLINFARM prepare full “Bioanalitycal Report”, which include all results, produced while bioanalytical phase of preclinical and clinical trial such as: * Validation Report * Analytical Report * Statistic Report We archived and storage all studies reports not less 15th years.
CLINFARM using bioanalysis Technologies based on UPLC-MS/MS. GLP bioanalysis in CLINFARM are conducted in compliance with the Good Laboratory Practice Regulations (GLP). CLINFARM develops news origin bioanalytic methods and conducts validation of them according with FDA (Guidance for Industry for Bioanalytical Method Validation) and current EU’s requirements in this field. We conduct all investigations fast, quality, precision via our laboratory's equipments and scientists with many years’ pharmaceutical and bioanalytical study experience.
CLINFARM, in co-operation with clinic site, has experience in the planning and performance preclinical and clinical pharmacokinetic for Phase I/IIa studies of medicines and pharmacokinetic researches for generics – bioequivalence evaluation.
All biosamples (plasma or others) after drawing are put into crioboxes and then in deep-freezers (not more -35°C /-70°C) in clinic site. Specialized company conducts transportation of biosamples for analyses in crioboxes from clinic site to CLINFARM in maximum 24 hours. Controlled aliquots biosamples are stay storage in deep-freezers (not more -35°C /-70°C) in clinic site. After finish analytical phase of project CLINFARM also offers long-term, GLP-quality biosample storage at -35 °C or -70 °C (if required Sponsor’s contract).
CLINFARM conduct the bioanalytical phase of preclinical and clinical trials of medicines according to GLP, GCP. Study protocol must be written according to the GCP, Ukraine’s requirements are submitted to Ethical Committee (EC) and approved authority of Ukraine’s Ministry of Health.

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