Electronic Quality Management System (eQMS) and Electronic Trial Master File (eTMF)
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) 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; women-owned small businesses; or small disadvantaged businesses; and
(3) 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.
Project Summary
The purpose of this requirement is to determine and prioritize functional and technical requirements that meet the regulatory and compliance needs of the National Institute of Allergy and Infectious Diseases (NIAID) Intramural and Extramural Divisions and to understand the technology system and tool landscape for electronic Quality Management Systems and electronic Trial Master Files.
Specifically, NIAID is seeking:
• Commercial off-the-shelf (COTS) Electronic Quality Management System (eQMS) that can scale to support multiple divisions within NIAID.
• COTS Electronic Trial Master File (eTMF) that can scale to support multiple divisions within NIAID.
• Professional services to configure, deploy, train, validate, migrate existing documents, and support NIAID's use and adoption of the eQMS and eTMF systems.
• Ongoing support including maintaining compliance with changing regulatory requirements and mitigation of security vulnerabilities.
Please reference attached DRAFT Statement of Work (SOW) for background and project requirements.
Anticipated Period of Performance
It is anticipated that an award will be made on or about June 30, 2019 The base year period of performance is one year from the date of contract award plus four successive option years. The estimated total period of performance is July 1, 2019 through June 30, 2024.
Capability Statement/Information Sought
If your organization has the potential capacity to provide this eQMS and eTMF System, please provide the following information:
1. Organization name, address, point of contact, email address, website address, telephone number, DUNS number
2. Company location(s) and number of years company has been in business
3. Small Business Classification/Socio-Economic Status pursuant to the applicable NAICS code
4. Type of ownership for the organization
5. Are you the publisher or authorized partner/reseller for the eQMS and eTMF System and Professional Services?
6. Identification of any Best In Class contract vehicles including Government Wide Acquisition Contracts (GWAC) (e.g. GSA schedule, NITAAC) they may possess or are aware of that would support this possible requirement. If your organization does not provide the products/services under a GWAC, please identify availability as OPEN MARKET ONLY.
7. Company accreditations (e.g., International Standards Organization (ISO) accredited)
8. Number of staff within company: total number of staff and total number of staff supporting eQMS and eTMF products
9. Provide a list of tools, systems, and/or software that the company owns and operates other than eQMS and eTMF (e.g. eCTD, CRMS, CTMS, EDC)
10. List of Federal Civilian Customers
11. Tailored capability statement addressing the System requirements. Capability document shall be no more than 6 pages.
12. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.
Submission Instructions
Interested small businesses who consider themselves qualified to provide the above listed eQMS and eTMF System and Professional Services are invited to submit a response to this Sources Sought Notice by April 4, 2019 at 5:00 PM EST. All responses under this Sources Sought Notice shall be emailed to Tamara McDermott tamara.mcdermott@nih.gov.
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).
Tamara K. McDermott, Contract Specialist, Phone 406-375-7487, Email tamara.mcdermott@nih.gov
