Nonclinical project planning, management and execution

We can seamlessly work with your discovery and clinical teams to design the appropriate IND or CTD enabling studies, not only in terms of the indication, but also the timing of the execution of the studies. Our team can either support your in-house staff, or the selected preclinical CRO to manage the project during the in vivo and in vitro studies, through report writing and into regulatory filings.

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  • Development of nonclinical study project plans aligned with clinical study timeline
  • Review and update of nonclinical study plans/timelines in the light of nonclinical/clinical issues to minimize impact on overall development timelines
  • CRO study site evaluation selection
  • Toxicology study protocol preparation ensuring, innovative regulatory compliant, approaches to study design
  • Study monitoring, problem resolution and management of study issues
  • Study report preparation and finalization
  • Internal (client’s site) workshops and seminars on nonclinical drug development