Non-Clinical Development


Designing optimal non-clinical development programs to advance medicinal products

Non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic/toxico- kinetic (PK/TK) characteristics of drug candidates. If performed well, it can identify key ‘knock-out’ criteria, maximizing the chances of success in subsequent stages of development. Strategies for the non-clinical development of candidate drugs do not follow general regulatory guidelines but are developed on a case-by-case basis according to the specifics of the drug. It is essential to design an optimal non-clinical development program that enables the medicinal product to be taken forward to the next phase in clinical development, or to product registration.

Seamlessly integrating with your in-house experts

Venn has a team of non-clinical experts with broad experience who can guide you through all aspects of non-clinical development from lead candidate selection to market. Venn’s non-clinical experts can seamlessly integrate with your in-house experts and participate in multi-disciplinary development teams to facilitate accelerated drug development.

Venn Life Sciences can support you in:

Non-clinical Development

  • Designing and monitoring of non-clinical studies in all disciplines of toxicology as well as in PK/TK and metabolism studies (ADME)
  • Professional management of non-clinical projects and programs ensuring that scientific and regulatory milestones are achieved, timelines are met and budgets are respected
  • Taking responsibility for execution of your non-clinical development program, by selecting the most suitable Contract Research Organization (CRO), discussing study design, reviewing draft protocols, authorising final protocols and reviewing draft study reports on your behalf
  • Acting as the first point of contact with the CRO, enabling you to focus on other aspects of drug development
  • Development of regulatory non-clinical documentation (Investigators Brochure, non-clinical overview, non-clinical summary)
  • The performance of  PK/TK evaluations of bioanalytical data derived from all types of non-clinical studies. Hereto, the non-clinical department of Venn is accredited to perform these evaluations according to the principles of Good Laboratory Practice (GLP)

Learn more about Non-Clinical Development

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