COVID-19: NIAID Clinical Research Support Services (CRSS)

COVID-19：NIAID 临床研究支持服务 (CRSS)

• 批准号: 10582505
• 负责人: BAMBRA STROKES
• 金额: $ 416.76万
• 依托单位: PPD DEVELOPMENT LP
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2022-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10582505
• 关键词: Area; COVID-19; Clinical Data; Clinical Research; Clinical Trials; Contracts; Diagnosis; Disease; Immune; Immunology; Infectious Diseases Research; Laboratories; Mediating; Medical; Microbiology; Monitor; Monoclonal Antibodies; National Institute of Allergy and Infectious Disease; Outpatients; Prevention; Reporting; Research Support; Resources; Service provision; Services; Therapeutic; Therapy Clinical Trials; United States Dept. of Health and Human Services; United States National Institutes of Health; Vaccines; Writing; clinical diagnostics; clinical research site; data management; flexibility; product development; quality assurance; vaccine development

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The purpose of this contract is to provide a broad range of research support services to the current and evolving NIAID-supported clinical research portfolio. The contract enables the NIAID to establish and maintain the robust and flexible resources required to facilitate and advance infectious disease research and establish and maintain support for product development activities for high priority vaccine, other prevention and therapeutic approaches. Support will be provided in four broad clinical research areas: a) clinical research management; b) clinical site assistance; c) clinical trial management and d) clinical trial compliance. This project will provide support services for the COVID-19 ACTIV2 Outpatient Monoclonal Antibodies And Other Therapies clinical trial.

美国国家过敏和传染病研究所 (NIAID)、美国国立卫生研究院 (NIH)、美国卫生与公众服务部 (DHHS) 支持与微生物学和免疫学基本了解相关的研究，从而开发疫苗、治疗方法、用于预防、治疗和诊断传染病和免疫介导疾病的医学诊断。该合同的目的是为当前和不断发展的 NIAID 支持的临床研究组合提供广泛的研究支持服务。该合同使 NIAID 能够建立和维持促进和推进传染病研究所需的强大而灵活的资源，并建立和维持对高优先级疫苗、其他预防和治疗方法的产品开发活动的支持。将在四个广泛的临床研究领域提供支持：a) 临床研究管理； b) 临床现场协助； c) 临床试验管理和 d) 临床试验合规性。 该项目将为COVID-19 ACTIV2门诊单克隆抗体和其他疗法临床试验提供支持服务。