The Non-Clinical Development department of Kinesis Pharma BV can assist you in a broad range of activities within your development activities for small molecules as well as biological. These activities include ao:

• design of formal non-clinical development programs (according to applicable international guidelines)
• perform (GLP-) non-clinical (pharmaco- and toxico)-kinetic calculations, as test-site in a multi-site setting including preparation of protocols and reporting
• coordinate and monitor bioanalytical activities for non-clinical studies
• perform pre-study selection audits and select the appropriate CRO for the study to be performed
• coordinate non-clinical studies that are being performed as part of the development program, thereby acting as study monitor for a wide range of (multi-site) toxicity (including general tox, reproductive tox & genetic tox), safety pharmacology, ADME and PK/TK studies at contract research facilities. This activity also includes the discussion on- and review of the study design, protocol, study results and report with the CRO and Sponsor.
• contribute to non-clinical sections of and/or coordinate the overall production of CTDs, INDs, IBs and BLAs
• write non-clinical Expert Reports for (generic) compounds, based on study reports and/or literature
• ‘stand-alone’ reporting activities for (non)-GLP general tox, reproductive tox, genetic tox, toxicokinetics, and in vitro and in vivo ADME studies
• insourcing of TK experts, bioanalytical experts and/or study coordinators to organize, perform, monitor and/or report in house sponsor activities
• overall consultancy for non-clinical activities

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