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9 Pochaevskaya Str., Rubizhne, Lugansk region

+38 (050) 471-29-38

Clinical trials

PHARMBIOTEST is a Ukrainian contract research organization (CRO) providing a broad range of clinical research services for pharmaceutical, generic drug and healthcare companies. PHARMBIOTEST offers comprehensive clinical trial services on Phase 1–4 clinical research trials with emphasis on pharmacokinetic, bioavailability and bioequivalence studies. Our policy in quality management is founded on the established precepts of Good Clinical (GCP) and Good Laboratory Practices (GLP) which are embedded in all spheres of our activity, processes and procedures.

-    Study design
-    Study protocol
-    Determination a number of subjects to involve in a study and procedure of their randomization
-    Case Report Forms (CRFs) design
-    Informed Consent Forms writing
-    Full package of documents for submission to CTA
-    Ethics Committee submissions
-   Correspondence with CTA and Ethics Committee
-    Recruiting of subjects
-    Screening
-    Laboratory tests
-    Clinical stage of the study conducting
-    Adverse event reporting
-    Clinical data processing and statistics
-    Drug/metabolite assay method development and validation
-    Drug/metabolite analysis in biological matrices
-    Bioanalytical report writing
-    Bioanalytical data processing
-    Pharmacokinetic parameters calculations
-    Clinical/final report writing
-    Archiving
-    QA