THinc . . . a NONCLINICAL SAFETY DEPARTMENT
For clients who need support for nonclinical safety programs, we can help you develop the strategy for and manage a nonclinical program that is compliant with regulatory guidelines and smoothly moves drug candidates from the laboratory to the clinic.
Product Development and Planning
The smooth transition of drug candidates from the laboratory to the clinic requires expert planning, analysis, and interpretation of nonclinical results. As a member of the client project team, THinc can
- Provide expertise on the applicability and interpretation of the nonclinical findings
- Prepare strategic nonclinical program plans, timelines, and budgets
- Interpret guidance documents (e.g., FDA, ICH)
- Conduct due diligence assessments for in-licensing or funding proposals
- Perform gap analyses and assess nonclinical risk/safety profiles
- Participate in client project team meetings and advisory panels