With >20 years’ experience in clinical pharmacology, Biokinetica’s leaders have broad international expertise in conducting clinical studies based on complex protocols. These include first-in-human, Proof-of-Concept, bioavailability and drug metabolism studies, therapeutic equivalence, biosimilars, drug-drug interaction, dose escalation and others. Therefore, Biokinetica represents a unique combination of in-depth expertise in early clinical research, an experienced research team, outstanding subject housing conditions and expedited recruitment capabilities, all while maintaining the highest regard for subject safety and meeting stringent quality standards.
Together with our contracted partners, we provide comprehensive services from regulatory consulting and submission, protocol design, project management, to conducting and monitoring clinical trials through data management, biostatistics, clinical pharmacokinetic (PK), pharmacodynamic (PD) and medical writing services.
Our Early Phase Experts and Consultants Group provides protocol development consultation, safety evaluation and study results interpretation.
