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

DCP - 临床试验监管

• 批准号: 10658831
• 负责人: LEONARD FREEDMAN
• 金额: $ 50万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-31 至 2022-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10658831
• 关键词: Area; Caribbean region; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Contractor; Contracts; Development; Development Plans; HIV; Human Papillomavirus; Knowledge; Laboratories; Latin American; Monitor; Nursing Research; Performance; Phase; Procedures; Protocols documentation; Quality Control; Regulatory Affairs; Site; Specialist; Specimen; Therapeutic; Vaccines; cancer prevention; clinical development; experience; human biological material; operation; pre-clinical; process optimization; product development; programs; public-private partnership; quality assurance; research clinical testing; skills; therapeutic development

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.

承包商应根据要求开展项目分析活动，并提供现场工作人员协助制定疫苗和治疗药物的产品开发计划。承包商应提供以下领域的信息和知识，包括但不限于：产品（疫苗或治疗药物）开发分析;目标产品概况创建;临床前策略;生产能力分析;监管策略;临床开发策略，以及向高级阶段临床试验的过渡计划;候选人下选策略;以及公私合作伙伴关系的市场分析。承包商应确定这些方面的缺陷，并利用其自身和分包商的技能和能力独立弥补这些缺陷。