Nonclinical (preclinical) consultancy
The Kinesis Pharma nonclinical or preclinical consulting services range from designing the preclinical development plan (e.g. IND package) to facilitate the start of clinical studies to overall nonclinical consultancy, including, e.g., design of nonclinical studies during clinical development (e.g. 6 month tox, carcinogenicity, reprotox), due diligence aactivities, GAP analysis of preclinical development programs, review of development proposals c.q. stand alone study plans and dedicated advice in case toxicology issues arise.
The Kinesis Pharma nonclinical consultants aim to help the sponsor in making well-considered decisions during the drug development trajectory. In addition, the nonclinical experts can also participate in the sponsor’s multi-disciplinary development team(s) and take responsibility for all activities related to non-clinical development.
Questions that are handled by the Kinesis expert range from writing responses to questions obtained from authorities (FDA/EMA) to calculating a safe starting dose for a first-in-man study (NOAEL/MABEL) aand from advising on specific study findings (e.g QTc prolongation, or unexpected deaths in a study) to proposing a strategy on how to deal with high levels of metabolites (MIST guideline). Also for obtaining a second opinion on any nonclinical research issue/question, the Kinesis experts can be consulted.