DCP - Clinical Trials Regulatory & Monitoring Support for US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

The Contractor shall conduct program analysis activities upon request and provide on-site staff to assist in creation of product development plans for vaccines and therapeutics. The Contractor shall provide information and knowledge in areas including but not limited to: product (vaccine or therapeutic) development analysis; creation of target product profiles; preclinical strategy; manufacturing capacity analysis; regulatory strategy; clinical development strategy with transition plan to advanced phase clinical testing; candidate down-selection strategy; and market analysis of public-private partnerships. The Contractor shall identify deficiencies in these areas, and independently close those deficiencies using their skills and abilities and those of subcontractors.