Clinical Studies Network (CSN) Statistical and Data Coordinating Center (SDCC)

Please note: ALL OFFERORS MUST BE REGISTERED IN AND HAVE AN ACTIVE SAM.GOV ACCOUNT AT THE TIME A PROPOSAL IS SUBMITTED.

Questions may be submitted in accordance with Section L.7. INQUIRIES, and are due by email to the Contracting Officer by 12 PM ET on September 16, 2019. Answers to Potential Offeror's questions will be posted by a formal amendment to the RFP.

.

This requirement was previously synopsized in accordance with FAR 5.2 in FBO under https://www.fbo.gov/spg/HHS/OOS/OASPHEP/19-BARDA-DRAFT-CSN-SDCC/listing.html and https://www.fbo.gov/spg/HHS/OOS/OASPHEP/19-BARDA-DRAFT-CSN-(CTPE-SDCC-BSIP)/listing.html

Description

The Pandemic and All Hazard Preparedness Act Pub. L. No. 109-417, 42 U.S.C. § 241 et seq. (PAHPA: https://www.govinfo.gov/content/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf ) and The Pandemic and All Hazard Preparedness Reauthorization Act Pub. L. No. 114-255, (https://www.congress.gov/bill/114th-congress/house-bill/34/text) authorizes the Office of Biomedical Advanced Research and Development Authority (BARDA) to accelerate development and to improve the availability of transformative medical countermeasures (MCMs). These products include innovative vaccines, therapeutics, diagnostics, procedures, and medical devices to protect Americans from potentially fatal health security threats caused by intentional acts or that result from natural or accidental incidents. The required capabilities of the performance of the Clinical Studies Network (CSN) is to advance development of MCMs by efficiently enabling rigorous Phase 1-4 clinical trials to assess safety and efficacy of MCMs to save lives. The purpose of this solicitation is to extend and further refine the current CSN infrastructure and services available for advanced clinical development of MCMs.

Details for this requirement listed below are found in the Request for Proposal (RFP). With this solicitation, BARDA CSN seeks to engage a single Statistical and Data Coordinating Center (SDCC) Offeror to:

1. Establish the SDCC infrastructure to provide the following services:

a. study designs and data analyses;

b. a web portal for CSN-wide communication and document sharing/reviews;

c. 21 CFR Part 11 validated computer systems, standards/templates, standard operating procedures (SOPs), and project management;

d. archive for study data and trial master files (TMF) of completed studies;

e. data governance, transfer, integration and reporting system

f. BARDA CSN operations support

2. Provide the full scope of statistical and data management services for clinical studies in both routine and emergency response settings.

BARDA CSN seeks proposals from qualified vendors for establishing, maintaining and operating a stand-alone SDCC to provide statistical and data management services for clinical studies as well as to archive data and documents of completed clinical studies. The SDCC will enhance data harmonization across studies and facilitate Investigational New Drug (IND) applications, IND amendment publishing, and other Food and Drug Administration (FDA) submissions. The overall goal is to improve management of clinical studies' lifecycles more effectively and improve MCM development efficiencies by standardizing clinical study procedures and processes. The SDCC will be responsible for providing necessary and appropriate statistical and data management services and resources consisting of systems, procedures and expertise in statistical support, data management and information flow to support multiple medical countermeasure clinical trials. The systems that will be used to support clinical study data capture, management and analysis must be commercial off-the-shelf (COTS) platforms in order to facilitate integration within the CSN and with BARDA researchers in support of the BARDA mission.

This will be a full and open competition using the Indefinite Delivery, Indefinite Quantity (IDIQ) Mechanism as defined in FAR 16.5 (Indefinite Delivery Contracts). The intent is to award to one contractor a single IDIQ contract. The projected period of performance is five years, including a two-year Base CLIN and three one-year Option CLIN. Single-award task orders will be issued for services under the IDIQ. The SDCC awardee will be sole provider of services under this contract. The Contracting Officer will determine the individual task order type on a case-by-case basis. In the performance of task orders, the CO and Contractor shall use Cost Reimbursement including Cost plus Fixed Fee (CPFF), firm-fixed price (FFP), or cost-share.

Two other solicitations establish a Biological Specimen & Investigational Product storage facility (BSIP) and Clinical Trial Planning & Execution (CTPE) within the BARDA CSN. This solicitation addresses requirements for SDCC services only. Collectively, awardees from all three (3) solicitations will form the revised infrastructure for the BARDA CSN.

.