Small Business Sources Sought Notice - ASPR/BARDA Contract Research Organizations for Clinical Studies

Small Business Sources Sought Notice ASPR/BARDA Contract Research Organizations for Clinical Studies Special Notice No.: 19-BARDA-CSN-SBSSN-001 I. INTRODUCTION The purpose of this Small Business Sources Sought Notice (SBSSN) is to seek declarations of technical capabilities, data, and materials from qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, Veteran-Owned Small Businesses (VOSB), Economically Disadvantaged Woman-Owned Small Business (EDWOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB)]. The Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to provide maximum practicable opportunities in its acquisitions to all types and categories of small businesses. The proposed North American Industry Classification System (NAICS) for this proposed requirement is 541711. Please note that (Special Notice # 19-BARDA-CSN-OTSBSSN-001) Other Than Small Business Sources Sought Notice (OTSBSSN) will also be posted regarding this possible requirement, and is intended solely for prospective Offerors that are considered to be Other Than Small Business. Prospective Offerors should respond to the appropriate Sources Sought Notice relative to their business size standard. Your response to the information requested will assist the United States Government (USG) in determining the appropriate acquisition strategy, including whether a small business set-aside is a possibility. This SBSSN is not a Request for Proposal (RFP) and does not constitute a commitment by the USG. The USG is currently conducting market research in accordance with Federal Acquisition Regulation (FAR), Part 10, to identify potential small business sources to fulfill the requirement and gather information on current capabilities within the market. All information submitted in response to this Sources Sought Notice is voluntary and the USG will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the USG. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the USG and will not be returned. II. AUTHORITY The Biomedical Advanced Research and Development Authority (BARDA), Division of Contracts & Management issues this SBSSN on behalf of BARDA pursuant to FAR paragraphs 5.205(c) and FAR parts 10 and 19. III. PURPOSE This Notice seeks declarations of technical capabilities, data and materials from the public on current Good Clinical Practice (cGCP)-compliant clinical research organizations (CROs) and similar entities that are capable of managing some or all of the services required to conduct clinical trials of medical countermeasures (MCMs) for chemical, biological, radiological and nuclear (CBRN) threats, influenza and emerging infectious diseases. BARDA, within the ASPR at the U.S. Department of Health and Human Services (HHS), intends to use responses to this Notice for planning potential future acquisitions. This is not a request for proposals; BARDA will not award any contracts under this Notice. The objective of this SBSSN is to collect information about declared availabilities, capabilities, and other pertinent marketplace data about entities providing clinical trial support in order to strengthen BARDA's understanding of the current and future marketplace. BARDA will avail small businesses the maximum practicable opportunity to participate in BARDA acquisitions as either prime contractors (provided their technical proposal and business plan are in the competitive range), or as subcontractors to the prime. Potential future solicitations may include services, not necessarily full service, to conduct Phase I, II, III, and IV clinical trials or to provide specific services to support the development of MCMs for chemical, biological, radiological, and nuclear (CBRN) threats, influenza, and emerging infectious diseases. The goal of ASPR/BARDA is to enhance the ability of HHS to obtain quality products and services economically, efficiently, and lawfully. IV. BACKGROUND BARDA, within the Office of the ASPR at HHS, intends to use responses to this SBSSN for planning purposes towards the possible procurement of services from CROs and similar entities. In an effort to improve preparedness, the USG is seeking to re-define the current Clinical Studies Network (CSN) service capabilities to continue to support advanced clinical development of MCMs. BARDA is planning a new solicitation to further refine standing core functions and fill gaps in services of the existing CSN. BARDA established the CSN as a core service in 2012 and awarded Indefinite Delivery/ Indefinite Quantity (IDIQ) Contracts to five full service CROs in 2013 to form the CSN infrastructure. During the five years of the CSN's existence, several important gaps in capabilities were identified and will be addressed in the new solicitation. Additional needs of the CSN include: 1) Long-term storage capacity for records, investigational products (IP), and biological specimens; 2) A statistical services and data coordination center; 3) The ability to engage services on a routine basis without urgent timelines, and 4) The ability to engage services during a public health emergency (PHE) when rapid timelines are crucial. V. CAPABILITY STATEMENT/INFORMATION SOUGHT Capability statements submitted by potential sources in response to this announcement should demonstrate the respondent's qualifications and experience, specifically providing evidence as to their capability to meet these requirements, with particular attention to the technical areas specified below. Past performance is considered essential. In preparing tailored Capability Statements, interested parties are asked to identify relevant experience. V.I CLINICAL TRIAL PLANNING AND EXECUTION BARDA seeks a diverse pool of CROs or similar entities to provide clinical trial planning and execution 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 IP management, laboratory services, regulatory services, Institutional Review Board services, quality assurance, as well as other services. During public health emergencies (PHEs), 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 PHE (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) (i.e., VI.I.I and/or VI.I.II). V.I.I ROUTINE CLINICAL SERVICES?MINIMUM REQUIREMENTS - A quality-focused CRO or similar organization that has conducted infectious disease or chemical, biological, radiological, or nuclear threat clinical studies under a FDA Investigational New Drug (IND) application in the last 5 years. - Able to manage or subcontract all clinical trial planning and execution services specified above for Phase I - IV domestic and international clinical trials. - Compliant procedures aligned with all applicable International Council for Harmonization (ICH)-Good Clinical Practice (GCP) guidelines and U.S. Food and Drug Administration or global health regulatory authority regulations. - Ability to author IND documents and provide Regulatory Operations publishing and submission capabilities. - Must communicate and facilitate near real-time information sharing between all entities comprising the CSN, including the Statistical Services and Data Coordinating Center and the specimen and IP archiving facility. V.I.II RESPONSE CLINICAL STUDIES?MINIMUM REQUIREMENTS In addition to meeting all of the above, the Respondent must have: - Ability to respond to RFPs for task orders under very short timelines. - Ability to set up and conduct quality-focused clinical studies under very short timelines in order to meet a response scenario. - Internal systems and processes in place to support and protect worker safety and security in austere settings. V.II STATISTICAL SERVICES AND DATA COORDINATION CENTER BARDA seeks to engage a single CRO or similar entity to provide a statistical service and data coordination center to standardize data collection, management, and analysis across CSN studies. Services would include study design, an interactive web response system (IWRS) or an interactive voice response system (IVRS), data management, safety monitoring (Safety Monitoring Committee or Data and Safety Monitoring Board), medical monitoring and other data analysis and reporting services. This CRO would also provide a centralized clinical study records (i.e., Trial Master File) archive for indefinite long-term storage that meets regulatory requirements. The capability of providing innovative trial design and rapid trial start-up would be of critical significance to meet the challenges of developing MCMs for emerging public health threats. Additionally, access to data mining capabilities via health care utilization databases would be advantageous. V.II.I. STATISTICAL SERVICES & DATA COORDINATION CENTER?MINIMUM REQUIREMENTS - Ability to provide the full scope of statistical support ranging from development of study protocols and study-related documents such as statistical analysis plans (SAP) and clinical study reports (CSR) to providing data analysis and study result reports for regulatory submission and academic publishing purposes. - Ability to provide, manage, and support an independent Safety Monitoring Committee (SMC) or Data Safety Monitoring Board (DSMB). - Has operated a centralized clinical data -coordinating center (DCC) with harmonized practices, data standards, procedures, and templates in support of multiple clinical studies conducted by other CROs, sponsors and partners. - Capacity to provide the full scope of data management support (e.g., clinical database development and support, safety database development and support, IVRS or IWRS development and support, preparation of study-related materials and instructions, medical and drug coding, training of clinical site staff and assessment of clinical site capabilities for data collection and management, etc.); a system for integrating clinical data with the tracking of clinical specimens; and a data repository for completed clinical studies. V.III SPECIMEN AND INVESTIGATIONAL PRODUCT (IP) ARCHIVES BARDA seeks to engage a single facility for long-term storage of clinical study specimens (possibly non-clinical specimens) and IP across BARDA-supported studies. Services may extend to managing transport of clinical study specimens and IP for studies, laboratory services, end-of-study archiving, and managing future use of specimens (retrieving, aliquoting, labeling, shipping, tracking, etc.). V.III.I SPECIMEN AND IP ARCHIVES MINIMUM REQUIREMENTS - Has relevant expertise in management and operation of a 21 CFR Part 11-compliant clinical study archive, including receipt, storage, aliquoting, labeling, packaging, repackaging, shipping, temperature monitoring, acquiring, and disposition of clinical specimens, nonclinical specimens, and IP. - Storage conditions include room temperature, 2'C to 8'C,-20'C, -70'C, and liquid nitrogen. - Is prepared and able to store (or transfer) materials for periods that may extend in excess of 10 years. - Uses a widely available, validated, commercial inventory management and tracking system (21 CFR Part 11-compliant) with bar coding that can be readily linked to a third-party clinical study database without the need for significant or specialized computer programming. - Has the ability to manage and handle-either in-house or via a subcontractor-- specimens requiring special handling such as highly pathogenic and contagious specimens. ANTICIPATED PERIOD OF PERFORMANCE The Government anticipates awarding both single award and/or multiple award IDIQ Contracts with multi-year base periods of performance. The total period of performance including option periods is expected to be at least 5 years. PLEASE NOTE: - Potential Offerors are not expected to be proficient in all areas mentioned above. - Partnering and teaming arrangements are highly encouraged. VI. INFORMATION SUBMISSION INSTRUCTIONS If you have provided or plan on providing capability information with your response to the Request for Information 19-BARDA-CSN-RFI-001 posted December 18, 2018, prospective Offerors need not include that information for this Sources Sought Notice. Respondents are asked to provide only the most pertinent information, data, and materials necessary to convey adequately a declaration of capability in line with one or more of technical services requested in this Notice. Respondents are asked to state in their capability statement, whether they are responding to the SBSSN or the OTSBSSN. VI.I. BUSINESS REPRESENTATIONS Respondents must make business representations to ASPR/BARDA in the following order: a) Business Information Provide potential Respondent name, principal place of business, Data Universal Numbering System (DUNS) number, taxpayer identification number, number of employees, annual revenue of company, point of contact, and email address. b) NAICS Codes Provide your size classification relative to the North American Industry Classification System (NAICS) code 541711 - Research and Development in Biotechnology VI.II. RESPONSE FORMAT, TRANSMISSION, AND CLOSING DATE Respondents shall provide declarations of their capability to meet the requirements set forth in Part VI above. All information, data, and materials shall be in Microsoft Office, or Adobe Acrobat format. Interested qualified small business organizations should submit a tailored Capability Statement not to exceed seven (7) pages. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). Pages should be numbered. All proprietary information should be marked as such. VI.III. RESPONSE FORMAT, TRANSMISSION, AND CLOSING DATE Responses shall be submitted via email as follows: TO: Quintin Hackshaw at quintin.hackshaw@hhs.gov BY: 2 PM EDT on January 30, 2019 Any questions, comments, or concerns regarding this Notice shall be written and transmitted via email to the individual identified above. Respondents shall mark confidential, privileged, proprietary, trade secret, copyrighted information, data, and materials with appropriate restrictive legends. ASPR/BARDA will presume that any unmarked information, data, and materials were furnished with an "unlimited rights" license, as FAR subpart 27.4 defines that term, and ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials.