Over the past decade early phase clinical development has evolved towards an intensive, exploratory and knowledge-driven process, stimulated by the need to reduce attrition rates and to increase the chance of success in the expensive late stage of development.
For many years Kinesis Pharma has been a recognized leader for the provision of Phase 1 clinical trials, clinical pharmacology, pharmacokinetic and translational expertise as a partner for (innovative) pharmaceutical companies. With the involvement of well trained, experienced experts a large number of innovative early phase clinical development plans, clinical trial designs, protocols and clinical trial reports have been delivered, and subsequently approved by regulatory authorities or acknowledged in due diligence processes. Furthermore, many Phase 1 clinical trials, including first-in-man, bioequivalence and proof-of-concept in patients have been successfully coordinated by Kinesis. Our Scientific Publications section contains some examples of our involvement in Phase 1 clinical trials.
- Clinical Consultancy
- Medical Writing
- Clinical Trial Management
- Clinical Pharmacokinetics
- Clinical statistics and database programming
- Pediatric drug development
- Drug Safety / Pharmacovigilance Services
"Early phase clinical development is an intensive knowledge driven process"
Katsuhiro Mihara, RPh Ph.D.