TOXICOLOGY CONSULTING FOR REPRODUCTIVE SCIENCE

Leading Edge Pharmtox, Llc, Durham NC

Investigators

Abstract

The Contractor shall provide consulting services for NICHD CRB including but not limited to the following: • Review, monitor, and report on subject safety, protocol and regulatory compliance and data accuracy, as needed • Liaise between various research facilities and NICHD to ensure planned studies in the target product profile and the drug development program meet NICHD CRB objectives for regulatory submissions • Provide expert input regarding reproductive toxicology experiment design and procedures to NICHD staff who oversee grants, cooperative agreements or contracts, as needed • Review, evaluate, and provide expert consultation regarding safety issues for protocols funded on NICHD networks or other cooperative agreements or contracts • At the direction of NICHD staff, provide expert input to the network investigator team on clinical development plans, protocol designs, and risk assessments • Advise on reproductive pharmacology, and/or related, milestones, and evaluate project progress relative to established milestones • Recommend potential solutions to NICHD staff relative to reproductive toxicology for drug discovery and development, as needed