Preclinical Project Management
Kinesis Pharma has broad experience in designing,monitoring and coordinating nonclinical (preclinical) 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 preclinical studies, a full nonclinical project or program ensures that scientific and regulatory milestones are achieved, timelines are met and budgets are respected. Our preclinical project managers are nonclinical experts and can take full responsibility for execution of the preclinical development program (e.g. IND package), by selecting the most suitable Contract Research Organization (CRO), discussing study designs, authorizing study plans and reviewing draft study reports, all on behalf of the sponsor.
Kinesis has an extensive network of CROs for nonclinical studies that Kinesis works closely together with. Our preclinical project managers are perfectly able to advise on/choose the right fit for the sponsor. Selections are made on experience with the CRO, GLP and scientific quality of the CRO, specific knowledge/expertise, timelines, costs and ease of working together. In the end the sponsor decides on the CRO to work with. They can then advice on the study plans, 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 preclinical project managers can be the intermediate between CRO and sponsor.