SOURCES SOUGHT
B -- CRO Assistance for Long-term Storage, Distribution and Analysis of Biospecimens from the ACTIV-1 Master Protocol
- Notice Date
- 1/14/2022 7:05:35 AM
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95022Q00090
- Response Due
- 1/28/2022 7:00:00 AM
- Point of Contact
- Mark McNally, Phone: 3018275869, Rieka Plugge, Phone: 3018277515
- E-Mail Address
-
mark.mcnally@nih.gov, rieka.plugge@nih.gov
(mark.mcnally@nih.gov, rieka.plugge@nih.gov)
- Description
- Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. Background: To meet the unprecedented public health crisis created by the COVID-19 pandemic, the National Institutes of Health (NIH) announced on April 17, 2020 the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brings NIH together with its sibling agencies in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA); other government agencies including the Department of Defense (DOD) and Department of Veterans Affairs (VA);� United States Government COVID-19 Response; the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies. One of the programs established within the ACTIV framework was the Therapeutics Development Working Group that was charged with rapidly organizing and implementing clinical trials using adaptive platform trial designs that could test multiple agents and use shared control groups to accelerate testing and obtain much needed answers quickly to help guide clinical care of COVID-19 patients. The National Center for Advancing Translational Sciences (NCATS) and BARDA were asked to lead one of the ACTIV trials, ACTIV-1 Immune Modulators (IM), and implement the trial using the 60 US academic centers comprising the NCATS Clinical and Translational Science Award (CTSA) Program, plus additional non-CTSA US sites and sites outside the United States. Purpose and Objectives: The National Center for Translational Sciences (NCATS) Trial Innovation Network (TIN) is seeking CRO Assistance for the long-term storage, distribution and selected analysis of research samples collected from participants enrolled in the ACTIV-1 Immune Modulators (IM) Master Protocol. Research samples of whole blood, serum and plasma were collected during the trial from approximately 60 US academic centers comprising the NCATS Clinical and Translational Science Award (CTSA) Program and non-CTSA US sites.� These specimens were collected as part of the BARDA task order 75A50120F33002, contract number HHSO100201400002I, but the BARDA task order does not provide for long-term biospecimen storage and distribution after the conclusion of the ACTIV-1 trial, distribution of biospecimens and matched clinical data subsets from the trial or analysis of any biospecimens to answer exploratory aims from the ACTIV-1 trial.� These biospecimens that were collected for future research use from consented participants can provide critical data about the COVID-19 pandemic. Project requirements: The Contractor shall provide all the necessary services, qualified personnel, tools, materials, equipment, and facilities, not otherwise provided by the Government to perform the Statement of Work (SOW) herein: The contractor will provide long-term biospecimen storage after the conclusion of the ACTIV-1 trial; distribution of biospecimens and matched clinical data subsets from the trial to approved recipients; and selected cytokine analysis of any biospecimens, including statistical analysis, to answer exploratory aims from ACTIV-1.� The contractor will oversee these functions to include: management of necessary subcontractors, data management, any needed data monitoring, site monitoring of storage facility, statistical support, cytokine analysis of selected biospecimens related to ACTIV-1 IM exploratory outcomes, any assistance to the management of the cross-ACTIV virtual inventory portal for biospecimens, any regulatory assistance and arranging a commercial central Institutional Review Board (IRB) if needed. Key Personnel: Anticipated key personnel and qualifications are: Labor Category: Project Director Required Education:�MPH or equivalent with documented experience working with and understanding of implementation and management of clinical trials, related biospecimens and oversight of subcontractors Required Experience:�At least 5 years of relevant/related experience Duties:�Provide overall oversight for the project and management of project staff, all subcontractors and management of resources for the project.� Labor Category:�Project Leader Required Education: MPH or equivalent with documented experience in working with and understanding of implementation and oversight of complex clinical trials Required Experience:�At least 5 years of relevant/related experience Duties:�Main project leader to interface with the statistician for creation of needed datasets, facilitate communications, ensure any analyses are complete, and provide any needed communications with the biospecimen repository and the IRB of record. Labor Category: Statistician Required Education:�PhD or equivalent with documented experience in analysis of complex clinical trials Required Experience:�At least 5 years of relevant/related experience Duties:�Oversees the team providing statistical analysis for the cytokine analyses and creation of any clinical data subsets to be distributed with biospecimens. Labor Category: Bioinformatician Required Education:�PhD or equivalent with documented experience in analysis of complex laboratory data. Required Experience:�At least 5 years of relevant/related experience Duties:�Oversees the team providing statistical analysis for the cytokine analyses and creation of any clinical data subsets to be distributed with biospecimens. Labor Category:�Project Manager, Biorepository Required Experience:�Documented experience in working with and understanding of biospecimen storage and distribution from of complex, large clinical trials. At least 5 years of relevant/related experience Duties: Oversees the project and team providing long-term storage, distribution, and shipping of biospecimens from ACTIV-1.� Main point of contact. Ensures required reports are delivered. � Anticipated period of performance: Award is anticipated in February or March 2022, with a base period of performance of one year and four, one-year option periods. Capability statement /information sought: Responses to this notice must include sufficient information to establish the interested parties� bona-fide capabilities of providing the product or service.� The response shall include: the unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision.� Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. � Information regarding respondents�: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; The respondent must also provide their� DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. All responses to this notice must be emailed to Contract Specialist Mark McNally at mark.mcnally@nih.gov. �Responses must be received by 10:00 AM, Eastern Time, January 28, 2022. Disclaimer and Important Notes:� This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. � Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/b28fcba30f214b3d91f13ab3af756569/view)
- Record
- SN06218339-F 20220116/220114230104 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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