SOURCES SOUGHT
A -- National Institute of Allergy and Infectious Diseases (NIAID) Clinical Data and Safety Management Center (CDSMC)
- Notice Date
- 4/2/2020 11:07:44 AM
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N93020R00011
- Response Due
- 4/16/2020 12:00:00 PM
- Archive Date
- 05/01/2020
- Point of Contact
- Deborah Blyveis, Phone: 240-669-5143, Liem Nguyen, Phone: 240-669-5144
- E-Mail Address
-
blyveisd@niaid.nih.gov, liem.nguyen@nih.gov
(blyveisd@niaid.nih.gov, liem.nguyen@nih.gov)
- Description
- Introduction 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. Background Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases.� The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research that focuses on protective immune responses and immune-mediated diseases through grants and contracts awarded to domestic and foreign organizations. �A critical component of the Division�s mission targets clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics/genomics and/or other �omic�, and lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; (iv) primary immune deficiency disorders;(v) and other immune system disorders and treatments to enhance immune functions. Purpose and Objectives The purpose of this solicitation is to provide data management and clinical database oversight, a safety and pharmacovigilance management system and a sample tracking system in support of NIAID Clinical Research portfolio. Examples of these are: �Immune Tolerance Network (ITN) Asthma and Allergic Diseases Clinical Research Programs Atopic Dermatitis Research Network (ADRN).� Consortium for Food Allergy Research (CoFAR).� Inner City Asthma Consortium (ICAC) which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)� Autoimmune Diseases Clinical Research Programs Autoimmunity Centers of Excellence (ACE) Transplantation Clinical Research Programs Clinical Trials in Organ Transplantation (CTOT).� Clinical Trials in Organ Transplantation in Children (CTOT-C). Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA). Statistical & Clinical Coordinating Centers (SCCCs) Allergy & Asthma SCCC Autoimmune Diseases SCCC Transplantation SCCC Clinical Site Monitoring Center (CSMC) Regulatory Management Center (RMC) However, NIAID may use this acquisition to support domestic or international clinical research and clinical trials for high-priority NIAID-sponsored other research on a limited basis if the work is within the scope and aligned to the NIAID mission.� Project requirements The Contractor shall establish a Clinical Data and Safety Management Center (CDSMC) that will provide Data Management and Reporting, Clinical Safety and Pharmacovigilance, and a Specimen Tracking processes for NIAID supported clinical trials and studies (including mechanistic) for both domestic and/or international research. Scientific areas of support include allergic diseases and asthma; autoimmune disorders; immune-mediated rejection in solid organ, tissue and cell transplantation; primary immune deficiency disorders; and other immune system disorders and treatments to enhance immune functions. �� Data management, safety oversight and sample tracking activities currently being performed by Rho Federal Systems Division, Inc. (Rho), as described in RFA-AI-14-016 will be transitioned to a new contract award. The existing 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/argus-applications/overview/index.html).� Anticipated period of performance The anticipated period of performance comprised of the base period plus optional periods is five years and will start around December 2021.� Other important considerations Capability statement / information sought Interested respondents must submit a capability statement describing company�s experience and ability to perform the requirements that includes the following: A summary list of similar work previously performed, The professional qualifications and specific experience of staff who may be assigned to the requirement, Resumes for proposed key personnel, including the Principal Investigator, that reflect Education, and previous work relevant to the proposed requirement, Documented adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity, Documented adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources, Demonstrated ability to carry out the requirements. Page Limitations:� Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.� 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). All proprietary information should be marked as such. Required Business Information: DUNS. Company Name. Company Address. Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. Do you have a Government approved accounting system?� If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern�s name and address). Number of Copies: Please submit one (1) electronic copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Debbie Blyveis, Contract Specialist, at blyveisd@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF).� The e-mail subject line must specify 75N93020R00011.�� Facsimile responses will not be accepted.� Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM ET on April 16, 2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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 pre-solicitation 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://beta.sam.gov/opp/cb8b9e06bed34d44816f4f2feef57e6a/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05609160-F 20200404/200402230213 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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