Intelligent non-clinical design expedites development and maximizes clinical flexibility
ICON experts deliver in-depth experience to design and implement cost-effective non-clinical programs with speed and adaptability built-in. Clients benefit from a wealth of experience and knowledge to navigate the optimal path through the development process, for small molecules, large molecules, biologics and medical devices.
Our experts can identify underlying or unresolved safety issues in candidates, even those already in clinical development and resolve them, to maintain the development process. Working in conjunction with our CMC, clinical and regulatory teams helps to ensure that your non-clinical program is fully integrated.
Our key non-clinical development services include:
- Lead optimization
- Development plans and study design
- Gap analysis, due diligence, trouble-shooting and data interpretation
- Vendor selection, study execution and study management for efficacy and safety, pharmacology, toxicology, ADME/PK, biocompatibility
- Non-clinical sections for regulatory submissions ( IND, CTA, NDA, MAA, 510(k), PMA)
- Review and consultation on nonclinical and regulatory issues affecting submissions
- Representation at regulatory agency meetings