TOXICOLOGY CONSULTING FOR REPRODUCTIVE SCIENCE

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 Project Number: 75N94025P00320-0-0-1 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: WILLIAM KELCE | Institution: LEADING EDGE PHARMTOX, LLC, DURHAM, NC | Award Amount: $12,500 | Activity Code: N02 View on NIH RePORTER: https://reporter.nih.gov/project-details/75N94025P00320001