Inactive

Effective May 9, 2022 the subject solicitation has been cancelled. This RFP will solicit proposals for the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) that will provide a bro... Effective May 9, 2022 the subject solicitation has been cancelled. This RFP will solicit proposals for the Transplantation Statistical and 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. 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.

Inactive

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, analysi... 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."