We help our clients to execute their research and development strategies through our specific fusion of scientific, regulatory and business expertise. Our flexible approach helps manage risk and drives superior quality and performance for every client.
With >20 years’ experience in clinical pharmacology, Biokinetica´s Leaders have broad international expertise in conducting clinical studies based on complex protocols with the most demanding design, such as first-in-man, proof-of-concept, bioavailability and drug metabolism, therapeutic equivalence, biosimilars, drug-drug interaction, dose escalation and others. Therefore, Biokinetica Early Phase Institute represents the unique combination of in-depth expertise in early clinical research, an experienced research team, outstanding subject housing conditions and expedited recruitment capabilities while maintaining the highest regard for the subjects’ safety and quality assurance.
Together with our contracted partners, our service includes comprehensive coverage from regulatory consulting and submission, protocol design, project management, conducting and monitoring of 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.