SOLICITATION NOTICE
A -- Transplantation Statistical & Clinical Coordinating Center (T-SCCC)
- Notice Date
- 8/5/2020 10:28:36 AM
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- RFP-NIH-NIAID-DAIT-75N93020R00018
- Response Due
- 8/20/2020 12:00:00 PM
- Archive Date
- 09/04/2020
- Point of Contact
- Maribel Miranda, Phone: 2406695139, Tom Bahrami, Phone: 2406695147
- E-Mail Address
-
maribel.miranda@nih.gov, bahramit@niaid.nih.gov
(maribel.miranda@nih.gov, bahramit@niaid.nih.gov)
- Description
- The Contractor shall establish a�Transplantation Statistical & Clinical Coordinating Center (T-SCCC) that will�provide a broad range of support critical for the design, development, execution,�analysis, and reporting of clinical research sponsored by NIAID in transplantation.�The major clinical research programs supported by this solicitation include: Clinical�Trials in Organ Transplantation (CTOT) and Clinical Trials in Organ Transplantation�in Children (CTOT-C); in 2021 and thereafter, the Clinical Trials in Organ�Transplantation in Children and Adults (CTOT-CA); the Immune Tolerance Network�(ITN); investigator initiated clinical trials (IICT), and other clinical trial/study�activities supported by NIAID herein collectively referred to as NIAID supported�research.�The scope of functions performed by the T-SCCC includes:�clinical study protocol consultation and development, design, planning, and�statistical analysis, preparation and distribution of assay kits for mechanistic studies�(Study Start-up); study initiation and management, interim reporting to study team, the sponsor, NIAID-Transplant Data Safety and Monitoring Boards (DSMBs)�and/or other regulatory oversight bodies, clinical safety and pharmcovigilance�support, safety oversight, management of study collaboration portals, interim�analyses, and bulk supply storage (including storage of kits, cryovials, labeling and�packaging equipment and supplies; assembling kits for mechanistic studies;�labeling kits; shipping kits [e.g., via FedEx]; distributing kits to laboratories for�mechanistic assays; tracking kits; biospecimen tracking in sites and laboratories�conducting mechanistic studies and assays; and magement of biospecimen�repositories) (Study Conduct); data analysis, data reporting, presentation and�abstract/poster/manuscript preparation, the final study report (Study Closeout). The statistical and clinical support functions 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� (https://www.oracle.com/partners/en/products/applications/argusapplications/overview/index.html). Any responsible offeror may submit a proposal which will be considered by the�Agency. This RFP will be available electronically on/about August 20, 2020, and�may be accessed through https://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 online via the�NIAID electronic Contract Proposal Submission (eCPS) website. Submission of�proposals by facsimile or e-mail 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/6c3a734fa56c4f0bac8a76dfa3f01b4f/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05745751-F 20200807/200805230153 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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