Clinical Trials Accrual Quality Improvement Program (AQuIP) Data and Information Technology Support for the US-Latin American-Caribbean HIV/HPV Prevention clinical Trials Network (ULACNet)

NOTICE OF INTENT TO SOLE SOURCE: The Department of Health and Human Services, NIH, NCI, OA on behalf of the National Cancer Institute, Division of Cancer Prevention (DCP) intends to award a sole source, bridge, Firm-Fixed Price (FFP) contract under the procedures of FAR subpart 13.106-1(b)(1), via a Request for Quotation (RFQ), to Technical Resources International (TRI), 6500 Rock Spring Dr, Bethesda MD 20817. These services are to continue ULACNet clinical trials Accrual Quality Improvement Program (AQuIP) data and information technology support, utilizing the data capture system designed by TRI. TRI is uniquely qualified to continue support for the ULACNet AQuIP effort, as they designed and are currently managing the Accrual On-Line Reporting System (OARS database) system, This requirement will provide ongoing accrual data management services including the maintenance, integration, collection, review, analysis, storage, archiving mechanisms and reporting of per-person, per-site, per-study level accrual data, and related information collected from ULACNet multi-language clinical trial sites in partnership with the DCP. This requirement entails maintaining a short-term contract to ensure continuous support by the incumbent contractor pending the build out of anticipated, competitive requirements for the development/expansion of the AQuIP networks. The anticipated, sole source, contract may include options, but will not extend beyond a 24-month Period of Performance. Currently, it is the Government's understanding that no other sources have the capabilities of meeting this short-term procurement. The NAICS code for this requirement is 541990 - - All other Professional, Scientific, and Technical Services. The Small Business size standard is $19.5 Million. The specialized support will require a vendor to perform the following: a. The Contractor shall provide the services required to enhance, host, and maintain the Accrual Quality Improvement Program (AQuIP) On-line Accrual Reporting System (OARS) for the collection and management of clinical trial accrual data for ULACNet studies that are compatible with DCP enterprise applications for the routine exchange of data as required. b. The contractor shall use standards adopted by the National Cancer Informatics Program (NCIP) that promote semantic and syntactic interoperability and compatibility among data and systems and ensure compliance with all applicable standards for data and systems integrity, confidentiality, and security. NCI Center for Biomedical Informatics and Information Technology (CBIIT) resource page (https://datascience.cancer.gov/resources) and Cancer Data Standards Registry and Repository CDE portal (https://cadsr.cancer.gov/onedata/Home.jsp) c. The contractor shall provide services to support, maintain, and/or enhance the systems for submission and reporting of clinical trial data including but not limited to accrual data for ULACNet studies. d. The contractor shall comply with federal requirements for retaining all participant and study data for a period specified by federal regulations after the termination of an IND, after the approval of a New Drug Application (NDA) or Product Licensing Application (PLA), or when an IND is not filed CFR - Code of Federal Regulations Title 21 (fda.gov)[1] e. The contractor shall consult with the COR regarding potential risks to the integration, implementation, and maintenance of all software and hardware required for AQuIP. f. The contractor shall ensure that NCI systems remain continuously operationally available 24 hours a day, seven days a week. Any system maintenance or updates that will interrupt the operation of the systems shall be performed outside of normal working hours (weekdays 6:00 am to 6:00 pm ET) to ensure minimal disruption. Any emergency updates that need to be performed during normal working hours shall be performed only upon approval of the COR. g. The contractor shall perform all periodic operational tasks required to maintain the proper level of performance and data integrity of all systems developed, hosted and/or managed under this task order. This shall include enhancement of system programs, data quality; change management; configuration management; requirement analysis; verification and validation; initial coding; revision; testing; debugging; documentation; training for all system software and hardware; and systems and/or data integration. h. The contractor shall use a formal process for collecting, tracking, assessing, approval and implementation of change requests, which shall originate from the COR. The COR shall approve any change to an active application that requires the equivalent of 40 hours or more to complete prior to the Contractor's change. The Contractor shall coordinate and monitor this activity to ensure effective legacy migration and future system transformation. i. The contractor shall maintain and improve software and hardware assets that require periodic updates including procurement activities prior to the expiration of any asset or its license or certification needed to provide services for optimal performance of NCI systems. The contractor shall maintain all supplier agreements to provide services for software and hardware to ensure server functionality and optimal fault tolerance. j. The contractor shall oversee AQuIP OARS user account management/creation. k. The contractor shall track AQuIP submission compliance and provide quality control of routine and ad hoc data submitted to DCP and to the clinical sites. The contractor shall query the data overall for errors, and work with the sites to resolve all data discrepancies. Data queries to the sites shall be written in the appropriate local language. Data from international partners may be submitted in the local language and shall be translated to English by the contractor. l. The contractor shall diagnose and resolve problems identified in AQuIP within 30 days. m. In the event of a major natural disaster (i.e. weather, earthquake, etc.) or man-made disaster (i.e., power outage, etc.) causing a shutdown of DCP operations, the contractor shall ensure that all systems developed to collect, report or store participant level data shall be fully operational within 24 hours. n. The contractor shall maintain the Helpdesk in support of ULACNet AQuIP. o. The process for ULACNet AQuIP data collection, data submission, review/query, and Zone Monitoring Report (ZMR) creation/distribution would be as follows: 1. The contractor shall translate the AQuIP Excel file template into appropriate site local language(s). 2. The content of each AQuIP Excel template (i.e., the English, or local language versions) will match the content (e.g., dropdown lists, etc.) that is in the current AQuIP OARS system, and each language specific AQuIP Excel template will be updated to align with any future AQuIP OARS updates. 3. The contractor shall continue the current process for collecting the monthly local language AQuIP Excel files from each accruing organization for each study by the 10th of each month. The contractor shall have five (5) business days for the translation and review of the AQuIP Accrual Excel Report free text fields and to query each site in the appropriate local language and in English for any discrepancies. The contractor shall enter the accrual information collected into the OARS database. 4. The contractor shall collect from the Lead Academic Organizations (LAOs) the Recruitment Journal Study Events spreadsheet by the 10th of the month, or the next business day if the 10th is a weekend or holiday, and the journal information shall be entered into OARS by the contractor. 5. After the AQuIP Accrual Excel Report has been reviewed and translated, the contractor shall have two (2) business days to batch upload spreadsheets, including free text information, into AQuIP OARS. 6. The contractor shall have five (5) business days to produce the Zone Monitoring Reports in English and local languages, as appropriate, and distribute to DCP and the appropriate LAO, and clinical trial accrual site(s). The ZMRs shall include but not be limited to cumulative accrual data (i.e., participant-, site-, and study-level data) by network, by study, by clinical accrual site, etc. Routine monthly reports and graphs shall be distributed to DCP staff and clinical trial sites in English and applicable local language(s), as appropriate for all accruing sites, and studies in the network. 7. The contractor shall ensure that authorized DCP staff have database access with the ability to perform ad hoc database queries. 8. The contractor shall create reports in response to governmental or other organizations requests for accrual information and AQuIP data (for example, Data Safety and Monitoring Board (DSMB), Food and Drug Administration (FDA), Freedom of Information Act (FOIA) requests, etc.). 9. The contractor shall provide support ad hoc for AQuIP data reports and/or graphs for presentations, manuscript preparation, and other publications as requested by DCP and ULACNet staff. 10. The contractor shall provide ad hoc accrual metrics for use in assessing the past or current performance of designated study sites, including measures of AQuIP data quality and timeliness of data and document submissions, as requested by DCP. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. Responsible sources may identify their interest by submitting capability information, which, if received within fifteen (15) calendar days of publication of this notice, shall be considered by the NCI OA. A determination by the Government not to compete this proposed contract, based upon responses to this notice, is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All inquiries and submittals must be sent via email to Ms. Sheila Ramos, Contracting Officer at sheila.ramos@nih.gov by 3:00 PM Eastern Time (ET) on March 01, 2024. Telephone inquiries shall not be accepted.