Pre-Clinical R&D Planning

Our Preclinical R&D Planning Practice helps our clients develop successful research strategies that bring their products into clinical trials. With broad expertise in experimental science, our Preclinical R&D Planning professionals provide services that cover all aspects of the preclinical phase of development, from the initial scientific evaluation through planning of the product manufacturing.

The Preclinical R&D Planning Practice provides our clients with strategies for:

  • Technology assessment and evaluation. We have in-house expertise in experimental science and can review and evaluate scientific results, and can also help our clients develop a research strategy. In addition, we can assist our client in evaluating competing technologies and in developing a strategy to achieve a technical competitive advantage.
  • Assay design, to detect active compounds and to measure biological activity.
  • Preclinical animal models. We can help design studies and interpret the results of in vivo testing. Our team has experience with a variety of animal models and recommends models that are best suited to our clients' drug-testing needs.
  • Toxicology, for the design of animal safety testing programs that support clinical testing of a product in man. We also arrange for toxicology studies and the preparation of documentation for submissions to regulatory agencies.
  • Drug optimization design, with particular expertise in the design of protein drugs to regulate biological half-life and potential immunogenicity. We can also establish criteria for product characterization, purification and formulation.
  • Strategies for drug manufacturing, which include determining the best method for manufacturing the product, evaluating potential manufacturing facilities and formal auditing of those potential facilities.