SOLICITATION NOTICE
A -- ALLERGY and ASTHMA, STATISTICAL & CLINICAL COORDINATING CENTER
- Notice Date
- 8/3/2020 9:21:03 AM
- Notice Type
- Presolicitation
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- RFP-NIH-NIAID-DAIT-75N93020R00019
- Response Due
- 8/21/2020 12:00:00 PM
- Archive Date
- 09/05/2020
- Point of Contact
- Brandon de White, Phone: 2406695149, Tom Bahrami, Phone: 2406695147
- E-Mail Address
-
whitebra@niaid.nih.gov, bahramit@niaid.nih.gov
(whitebra@niaid.nih.gov, bahramit@niaid.nih.gov)
- Description
- Presolicitation Notice Information Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of�Health (NIH), of 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 NIAID, Division�of Allergy, Immunology, and Transplantation (DAIT) has a requirement for Asthma and�Allergic Diseases Statistical & Clinical Coordinating Center (AA-SCCC) which will provide a�broad range of support critical for the design, development, execution, and analysis of�clinical research sponsored by DAIT in allergic diseases and asthma. � Description The Contractor shall establish an Asthma and Allergic Diseases Statistical & Clinical�Coordinating Center (AA-SCCC) which will provide a broad range of support critical for the�design, development, execution, and analysis of clinical research sponsored by DAIT in�allergic diseases and asthma. The clinical research to be supported by the Center includes:�(i) clinical trials at all phases to evaluate the safety and efficacy of investigational products�and innovative approaches for disease treatment and prevention; (ii) studies of underlying�mechanisms as integral components of clinical trials; (iii) observational clinical studies (e.g.,�longitudinal birth cohort studies, genetic studies, studies designed with the main purpose to�assess mechanisms of disease etc.); and (iv) surrogate/biomarker studies. The scope of�statistical and clinical monitoring functions to be performed by the Center includes statistical�design and analysis, protocol development, study initiation and management and�management of sample repositories. The statistical and clinical support functions are currently being performed by Rho Federal�Systems Division, Inc. (Rho), as described in RFA-AI-14-016 will be transitioned to the�awardee of this contract. Currently, the clinical databases are managed through Medidata�s�cloud-based Rave Electronic Data Capture (EDC) software�(https://www.medidata.com/en/audience/data-management/), while the safety database is�managed thru Oracle Argus On-Premise Enterprise software .� Any responsible offeror may submit a proposal which will be considered by the Agency. This�RFP will be available electronically on/about 8/20/20 and may be accessed through beta.sam.gov http://www.beta.sam/gov/. This notice does not commit the Government to�award a contract. No collect calls will be accepted. No facsimile transmissions will be�accepted. For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic�Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or email�is not acceptable.�For directions on using eCPS, go to the website https://ecps.nih.gov and then click on ""How�to Submit.""
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/a2ad8cac38e6424eab3b330120241ad4/view)
- Record
- SN05742680-F 20200805/200803230142 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |