We can...

1. help companies integrating reprotoxicity and genotoxicity data into appropriate contraception requirements in clinical trials for adults and pediatric population as well as integrate this information into the core data sheet and other labeling documents.
2. guides the selection of candidate compounds and implementation of prospective suicidality assessments in clinical trial protocols meeting FDA requirements.
3. serve as a resource for support and guidance for safety signal detection and risk/benefit assessment and associated processes.
4. offer Global Project Medical Director level support for compounds in development in CNS
5. be an external resource for companies during the development of clinical trials protocols, CRFs and amendment preparations, IB compilations.