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Designing and monitoring non-clinical studies

Kinesis has broad experience in designing and monitoring non-clinical studies in all disciplines of toxicology (e.g., genotoxicity, safety pharmacology, general toxicology and reproductive toxicology), as well as in PK/TK and metabolism studies (ADME). The professional management of a non-clinical project or program ensures that scientific and regulatory milestones are achieved, timelines are met and budgets are respected. Kinesis can take responsibility for execution of the non-clinical development program, by selecting the most suitable Contract Research Organization (CRO), discussing study designs, authorizing protocols and reviewing draft study reports, all on behalf of the sponsor.

Kinesis has an extensive network of CROs for non-clinical work that Kinesis works closely together with and our non-clinical experts are perfectly able to advise on/choose the right fit for the sponsor. Selections are made on experience of the CRO, specific knowledge/expertise, timelines and ease of working together. In the end, the sponsor decides on the CRO to work with. The Kinesis Pharma non-clinical experts just advice in this, and can take over the contact with the CRO again after contracts are signed and studies are being initiated. The non-clinical expert can then advice on the study protocols, will be the first point of contact for the study director at the CRO and will coordinate in-life parts of the studies and the reporting of all study phases. Furthermore, the non-clinical expert will be the intermediate between CRO and sponsor.