Clinical Trial Management
From clinical trial design to clinical report
Kinesis is an independent CRO and not part of a clinical site. This enables us to objectively select the clinical site that has the best expertise to execute your study. In other words we do not design a study for a clinical site, but we select the best clinical site to investigate the objectives of your protocol. Within Kinesis the clinical trial management group has the expertise to set-up, organize, outsource, submit, and coordinate clinical trials and deliver clinical trial reports with focus on Phase 1/2 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, monitoring, analysis and reporting. Main services include:
- Creation or coordination of the production of necessary trial documentation, including protocols, subject information and informed consent, Investigator’s Brochure and IMPD.
- Management of all aspects of study medication.
- Identification and selection of 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.
- Writing and submission of the clinical trial application and management of other regulatory aspects of the study
- Supervision by clinical trial team during preparation, execution and reporting phase
- Coordination of communication with CRO’s and other partners regarding timelines, budget and quality of the clinical trial
- Data management
- GCP monitoring
- Statistics (including bioequivalence testing), analysis and reporting
Kinesis can support your projects from end-to-end, but also in modules, e.g. if you only need regulatory support, or only analysis and reporting.
We are aware of the special position of phase 1 and 2a studies in the drug development process of which many studies are performed in healthy volunteers. Timelines are short, and go no-go decisions have to be taken quickly. Kinesis has developed a key expertise in those early development clinical studies and is aware of their special requirements, including interim analysis where possible to obtain and use information as early as possible.