Nonclinical Program Design

Regulatory agencies offer sponsors guidance and regulations on what data is required for a product’s development, but there is not always clarity on when these studies need to be completed in respect to an investigational product’s stage of development.  Furthermore, while FDA and ICH guidelines provide structure to global nonclinical strategies, there are often nuances to regional study design and execution that should be considered. While nonclinical efforts are most often associated with the objective of reaching first-in-man studies, nonclinical programs run the lifecycle of the drug development process. PharmaLex assists its clients by working closely with them to carefully balance what is required for stage of development and registration while considering  the variables of time and cost.

PharmaLex works with clients to design a customized program that best suits the client’s needs. We place and monitor the program focusing on the following:

  • Nonclinical strategy
  • Program design
  • Competitive bids with cost analysis
  • Study protocol design
    • Dose selection
    • Animal model selection
    • Special population requirements
  • Regulatory Compliance
  • Analytical, bioanalytical, and validation methodology
  • Study monitor and oversight from protocol generations to final report