PHARMACOLOGY CONSULTING SERVICES

Gardner Pharmacology Llc, Vienna VA

Investigators

Abstract

The Contractor shall provide consulting services for NICHD CRB including but not limited to the following: The Contractor shall: 1. Liaise between various research facilities and NICHD staff to ensure planned studies achieve necessary pharmacokinetic requirements to meet NICHD CRB objectives 2. Evaluate existing non-clinical data and advise on optimal pharmacokinetic sampling strategies (including time points and matrices) 3. Provide review of contractor bioanalytical methodology to ensure accuracy and precision in accordance with FDA guidance 4. Perform preclinical non-compartmental pharmacokinetic data analysis (e.g., Winnonlin or equivalent software) generating basic pharmacokinetic parameters based on drug levels over time in plasma or other matrices 5. Prepare standalone pharmacokinetic reports and/or pharmacokinetic supplements for inclusion in existing study reports 6. In collaboration with a toxicologist(s), develop data models to jointly describe toxicology and pharmacokinetics 7. Provide guidance on drug dose, route of administration and frequency 8. Review, monitor, and report on subject safety, protocol and regulatory compliance and pharmacological data accuracy to NICHD staff, as needed 9. Provide expert input regarding systemic pharmacology experiment design and procedures to NICHD staff who oversee grants, cooperative agreements or contracts, as needed 10. Review, evaluate, and provide expert consultation regarding safety issues for protocols funded on NICHD networks or other cooperative agreements or contracts 11. At the direction of NICHD staff, provide expert input to the network investigator team on clinical development plans, protocol designs, and risk assessments 12. Review planned studies and clinical trials to ensure necessary pharmacology components essential for drug development are adequately included prior to initiation 13. Advise on milestones that utilize pharmacology experiments, and evaluate project progress 14. Recommend potential solutions related to pharmacology for drug discovery and development, as needed 15. Provide feedback to NICHD staff to improve successful pharmacology outcomes in line with scientific and program goals The Contractor shall have extensive experience with the rigorous design and conduct of assorted in vivo research studies. The contractor should have specialized expertise in pharmacokinetics, pharmacology, and Winnonlin data analysis.