The US Department of Health and Human Services, National Institutes of Health may have a continuing requirement for a contract to support a broad range of services critical for the design, development, execution, and analysis of clinical research in autoimmune diseases.

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The causes, pathogenesis, diagnosis, treatment, and prevention of autoimmune diseases are major areas of emphasis for NIAID’s Division of Allergy, Immunology, and Transplantation (DAIT). DAIT pursues research on autoimmune diseases by supporting investigator-initiated research projects, cooperative clinical studies, national networks of research centers, and demonstration and education research projects. A critical component of the Division’s mission focuses on clinical research to develop new and/or improved strategies to treat or prevent autoimmune diseases through rigorous evaluations of the safety and efficacy of investigational products and therapeutic interventions, studies to elucidate underlying mechanisms of disease, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of disease natural history.

This contract shall be administered and used primarily to support NIAID DAIT initiatives; however, NIAID may use this contract to support domestic or international clinical research or clinical trials for high-priority NIAID research on a limited basis, if the work is within the scope of and aligned with the NIAID mission.

The Contractor shall provide the following:

A. Statistical Design

• Provide expertise, advice and assistance pin the development of statistical design plans for the development of concept and full study proposals for NIAID supported clinical research;
• Provide assistance in the preparation of concept and full proposals and study-specific protocols;
• Provide assistance in the preparation of concept and full proposals and protocols for mechanistic studies;
• Provide support for preclinical safety study evaluation by providing statistical expertise for, and participate in, evaluating the accuracy and validity of data from preclinical safety studies in support of clinical trials if applicable;
• Provide assistance for clinical trials and mechanistic studies post-study initiation.

B. Statistical Analysis

• Development and preparation of the Statistical Analysis Plan (SAP) for each clinical trial in conjunction with the Study Management Teams (SMTs);
• Preparation of interim and final analyses;
• Preparation of summary data reports;
• Development and preparation of results for posting as required by ClinicalTrials.gov;
• Review of the accuracy and completeness of statistical data and data analyses for all abstracts, manuscripts, and presentations reporting on the clinical studies conducted by the relevant NIAID-sponsored networks and investigators prior to presentation or submission for publication.
• Collaboration with NIAID-supported research, including the NIAID Clinical Data and Safety Management Center (CDSMC);

C. Protocol Development and Study Initiation

• Provide expert advice and assistance to SMTs in the development of protocols for clinical trials and mechanistic studies;
• Provide expert advice, assistance and coordination in the preparation, writing, review and approval of protocol-related documents and materials in collaboration with NIAID, SMTs, and the CDSMC and other NIAID supported research.

D.Data Management and Reporting

E. Clinical Safety and Pharmacovigilance Center Support

F. Safety Oversight Structure Support

G. Clinical Study Internet-Based Collaboration Portals

H. Training

I. Repository of Biological Specimens

J. Other Technical and Administrative Support

K. Scientific and Technical Personnel

L. Facilities, Equipment and Other Resources

M. Quality Assurance/Quality Control

N. Overall Project Management

O. Initial and Final Transitions