Inactive

Introduction This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availabilit... Introduction This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Background The mission of the National Institute of Allery and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. NIAID has a unique mandate, which requires the Institute to respond to emerging public health threats. The mission of DAIDS is to increase basic knowledge of the pathogenesis, natural history, and transmission of HIV disease and to support research that promotes progress in its detection, treatment, and prevention. Per NIH policy, all clinical trials must be conducted in accordance with the International Conference on Harmonization (ICH) Guidelines: E6(R2) Good Clinical Practices (GCP), and country-specific regulatory requirements. Under ICH E6 (R2), essential trial documents are to be collected and stored within a Trial Master File (TMF), which it is the sponsor’s responsibility to establish and maintain. Trial master files should be established at the beginning of the clinical trial and the sponsor should maintain a record of the location(s) of their respective essential documents, including source documents. The storage systems used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval. The DAIDS global clinical trial portfolio includes approximately 150 active protocols, 80 active INDs, 100 network study sites in 15 countries, and collaborations with 60 pharmaceutical companies, and several of the clinical trials are high priority trials for which marketing applications are in process or imminent. This solicitation contributes to DAIDS meeting its overall mission through the provision of TMF consulting services to assist in decision making and development of standardized approaches by strengthening DAIDS’ knowledge of best practices related to the TMF regulatory requirement, thereby ensuring that DAIDS meets its regulatory obligations. DAIDS seeks to be judicious in expanding its TMF operations, and thus would like to first gain invaluable insight from experts in the TMF field prior to embarking on future TMF framework development. While DAIDS has some experience with TMFs, the Division is at a critical juncture of needing to scale up its TMF work but does not have the full expertise to evaluate best practices in all facets of the TMF field. Despite DAIDS having made recent decisions and updates regarding its TMF processes, the Division is seeking an assessment of its overall TMF framework and recommendations on the best TMF model which can allow strategic and agile expansion of its TMF work within any organizational limitations. Broadly, the purpose of this TMF consultant solicitation is for DAIDS to gain invaluable expert guidance on how to develop a comprehensive TMF strategy for its clinical trials according to applicable regulations so that TMFs remain in an inspection ready state and so that TMF documents are filed contemporaneously throughout the course of its clinical trials. DAIDS has experience in implementing various TMF formats, including paper, mixed paper and electronic, and electronic TMFs. While DAIDS has assembled its own TMFs, it has recently been working with and overseeing contracted vendors who develop, implement, and manage electronic TMFs (eTMFs) on its behalf. Additionally, DAIDS has experience with centralized, decentralized, and mixed centralized/decentralized TMFs. DAIDS has moved to a decentralized eTMF approach whereby collaborators with regulatory-compliant eTMFs maintain documents in their purview within their own eTMFs, and documents from those collaborators that do not have a regulatory compliant eTMF are managed centrally in a vendor’s eTMF. The DAIDS TMF Index has had different formats, but as of August 2021, DAIDS has transitioned to the Drug Information Association (DIA) Reference Model for its TMF Index. DAIDS does not currently have an eTMF system (i.e., infrastructure, training program for DAIDS staff, etc.) in place to manage TMFs. There are multiple eTMF electronic platforms available, some of which can comply with the Federal Government security requirements. DAIDS stakeholders use various eTMF systems. The contracted DAIDS Regulatory Support Center (RSC) which currently develops, implements, and manages a majority of the current eTMFs for DAIDS, uses the Veeva Vault eTMF. DAIDS has been collaborating with the NIAID Office of Cyber Infrastructure and Computational Biology (OCICB) on a NIAID procured eTMF, so an eTMF procurement would be out of scope for this solicitation. However, the scope of this TMF consultancy should consider the timing of OCICB’s planned eTMF procurement and any other practical considerations in recommendations made regarding the TMF strategy options posed to DAIDS. Purpose and Objectives The purpose of the proposed acquisition is to provide expert Trial Master File (TMF) consultants to review DAIDS TMF processes and assist DAIDS in the creation of a strategic, agile, and sustainable TMF framework that helps support a holistic approach to management of TMFs. The specific TMF consultancy requirements are to: perform an assessment of the DAIDS clinical trials research enterprise against the existing TMF operations, systems, and workflows, and identify potential sponsor compliance gaps and ways that DAIDS can strategically bring to scale its TMF sponsor responsibility-driven activities in a realistic, quality focused, and achievable TMF framework; determine DAIDS current TMF capabilities, and identify opportunities for DAIDS to achieve near- and long-terms regulatory inspection-ready TMFs and oversight processes; recommend to DAIDS comprehensive, realistic, quality-driven, holistic, agile, and achievable, strategies for its TMF system within a strategically defined timeframe, and assist DAIDS in selecting the best strategy which suits the organization; facilitate communication and expansion of the DAIDS-selected regulatory-inspection-ready TMF implementation for scale-up, and train DAIDS staff and stakeholders on the selected TMF strategy. Anticipated period of performance It is anticipated that an award will be made on or about 9/30/2022. The base year period of performance is 6 months from 09/30/2022 through 3/29/2023 with an option to extend for an additional 6 months if needed. The estimated total period of performance of option 1 is 03/30/2023 through 9/29/2023 Capability Statement/Information Sought Interested contractors must submit individual capability statements describing their company’s experience and ability to perform this effort, which includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Capability statements submitted as a result of this announcement should demonstrate the Offeror’s qualifications, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey information regarding the respondent’s capabilities, including: (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. Each response should include the following Business Information: a. UEI number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought or other Government-Wide Contract g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract, including that performed by any subcontractors and consultants. The Contractor shall ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Page Limitations: Interested organizations should submit a tailored Capability Statement, not to exceed five (5) 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. Number of Copies: Please submit one (1) electric 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 Callie Prassinos at Callie.Prassinos@nih.gov. The capability statements should be submitted Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify “DAIDS Trial Master File TMF Consultant”. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due not later than 12 PM (E.S.T.), Monday, 08/19/2022. CAPBILITY STATEMENTS WILL NOT BE RETURNED AND WILL NOT BE ACCEPTED AFTER THE DUE DATE. 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).