Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTPE)

AMENDMENT 2: To answer question #12 from Amendment 1. .

AMENDMENT 1: Offerors should review all pages of the Amendment and provide acknowledgement of receipt of the Amendment as required on the SF 30 part 11. The receipt of proposals due date is extended to Monday October 28, 2019 at 12 pm Eastern Time.

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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 23, 2019. Answers to Potential Offeror's questions will be posted by a formal amendment to the RFP.

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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-CTPE/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 Clinical Trial Planning & Execution (CTPE) request for proposal (RFP). With the CTPE solicitation, BARDA CSN seeks to engage multiple Offerors to:

1. Provide clinical study core services for use on a routine or response basis by BARDA and by BARDA's product development partners.

2. Enhance BARDA's preparedness and response clinical service capabilities to chemical, biological, radiological, and nuclear (CBRN), Pandemic Influenza (PI) and emerging diseases (EID) threats.

3. Promptly complete clinical activities supporting regulatory applications including but not limited to emergency use authorization (EUA).

4. Improve financial management of clinical trials and potentially reduce the MCM clinical development costs to BARDA.

5. Reduce the risk associated with clinical development of investigational or repurposed products by expanding the available clinical data

BARDA CSN seeks to engage multiple Offerors for the purpose of establishing a diverse pool of clinical research organizations (CROs) or similar entities to provide CTPE services as primary contactors. Service capabilities include project management, study start-up, site training and support, site feasibility and selection, site monitoring and management, specimen and investigational product management, central laboratory services, regulatory services, Institutional Review Board services, quality assurance, as well as other services as described in the RFP. During emergency situations including public health emergencies (PHEs)[AK(1] [RW2] , services need to be rapid, adaptable, scientifically robust, and minimally disruptive to the course of patient care. Considerations for executing such services need to include:

1) Phase of the study in relation to the development stage of the MCM investigational product (Phase I, Phase II, Phase III, or Phase IV)

2) The type of study (e.g., interventional or observational studies)

3) The requirement for near real-time data availability

4) The scale of the emergency (e.g., national versus local versus international)

5) The class of MCM (e.g., drug, biologic, device, or combination product).

BARDA acknowledges that some Respondents may have strengths in providing these services in the conduct of routine (i.e., preparedness) studies, while others may have strengths operating in response (i.e., emergency) scenarios. Therefore, BARDA intends to evaluate Respondents separately for these two capabilities. Respondents may respond to one or to both capability(ies).

This will be a full and open competition using the Indefinite Delivery, Indefinite Quantity (IDIQ) or Requirements Contracting Mechanism as defined in FAR 16.5 (Indefinite Delivery Contracts). The intent is to award multiple-award IDIQ contracts for the 'CSN Clinical Trial Planning & Execution (CTPE) ¾Routine Clinical Services and/ or CTP & E¾Response Clinical Services.' The projected period of performance is five years, including a two-year Base CLIN and three one-year Option CLINs. Task orders will be competed under the IDIQ providing all IDIQ holders a fair opportunity to compete. 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).

Two other solicitations establish a Biological Specimen & Investigational Product storage facility (BSIP) and a Statistical and Data Coordinating Center (SDCC). Collectively, awardees from all three (3) solicitations will form the revised infrastructure for the BARDA CSN. This solicitation addresses requirements for CTPE services on a routine basis without expedited timelines, as well as services to prepare for and execute clinical studies during emergencies when expedited timelines are crucial.

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