Clinical Trial Operations
End-to-End support for clinical studies
Kinesis’ clinical trial operations group has the expertise to set-up, organize, outsource, submit, coordinate and deliver clinical trials. Timely delivery of high quality clinical trial results is the primary objective. Kinesis can support your company in each aspect of clinical trial design, execution, analysis and reporting.
Main services include:
- Creation or coordination of the production of necessary trial documentation, including protocols, patient information and informed consent, investigator’s brochure
- Management of all aspects of study medication. Consultancy on CMC and preparation of IMPD
- Identification and selection the best clinics or Contract Research Organizations (CROs) for the needs of the protocol, clear of any selection bias. Kinesis will select the best sites with the clinical expertise related to your study.
- Management of all regulatory aspects of the study
- Pharmacovigilance
- Coordination of the clinical execution
- Data management
- ICH-GCP monitoring
- Statistics, analysis and reporting.
Flexibility in Clinical Trial Operations
Kinesis can support your projects from end-to-end, but you can also decide to use only some aspects of our services. We are flexible and can deliver services in modules. If you only need regulatory support, or only analysis and reporting, you are very welcome.
Special Expertise
The Kinesis staff members have developed special expertise in some area’s in clinical development:
Early development
Kinesis has developed a key expertise in phase I and IIA studies. Kinesis staff members have a long standing experience in major pharmaceutical companies and knowledge of the special requirements for these studies.
We can give consultancy on the optimal trial design in relation to pharmacokinetic, pharmacodynamic and safety parameters. Kinesis is not part of a CRO or clinic. This will enable us to independently select the clinical site that has the best expertise to execute your study.
We are aware of the special position of early development studies in the pharmaceutical development process. Timelines are short, and go no-go decisions have to be taken quickly. Kinesis will commit to your timelines and will make sure your early development process will be completed in the most efficient way.
Clinical Pharmacology and Pharmacokinetics
What is in the name? Kinesis founders have a major expertise in pharmacokinetics. Pharmacokinetic and pharmacodynamic analysis and modeling are core expertises within Kinesis, and so all aspects of setting up, management and execution of these studies. Your bioequivalence or bioavailability study is in good hands with Kinesis.
Pediatric studies
Pediatric studies require additional attention to the safety of the subjects. Kinesis has in-house expertise on the special regulations for pediatric studies. We can give consultancy on the study design but of course, we can make sure your pediatric study will be executed with the highest quality. For pediatric drug development, Kinesis works in close collaboration with the MCRN. Both parties have extensive experience in the field of development and evaluation of medicines in pediatric use; Kinesis from the industrial and regulatory angle, the MCRN from the clinical approach.