CROMS 2.0_Statement Of Work_Draft.pdf

Statement of Work National Institutes of Health National Institute on Aging

Clinical Research Operations & Management System

(NIA CROMS) 2.0

1. General This requirement is for the NIH NIA Clinical Research Operations & Management System (NIA CROMS) in support of the National institute of Health (NIH), National institute on Aging (NIA), Division of Extramural Activities (DEA), Office of Clinical Research (OCR).

2. Background

The National Institute on Aging (NIA), one of the 27 Institutes and Centers (ICs) of the National Institutes of Health (NIH), leads the federal government in conducting and supporting research on aging and the health and well-being of older people. Through NIA’s extramural research program, the Institute oversees a clinical research portfolio, which utilizes a variety of grant mechanisms that span across four divisions (Aging Biology, Behavioral and Social Research, Geriatrics and Clinical Gerontology, and Neuroscience), and multiple disease areas. Over the last several years, NIA’s budget has tripled ($4.4 billion in 2024), resulting in substantial growth in its operations as well as its clinical research portfolio, number of grantees, participating sites, and clinical research data to manage.

Currently, the NIA Extramural Research Program (ERP) stands as the primary funder for thousands of unique active grants, encompassing a broad spectrum of clinical research that necessitates informed consent from human participants, including human subjects research studies and NIH-defined clinical trials. NIA funds and supports all stages of research including basic, clinical, translational, and epidemiological studies focused on Alzheimer’s Disease and Related Dementias (ADRD) of aging, as well as geriatrics and gerontology focused-research into health and disease in the aged, and research on aging over the human life span and its relationships to health outcomes. Clinical studies vary by target enrollment goals and span from small, short-term, pilot evaluations involving a single site, to large, multi-year, multi-site clinical studies. They include preventive and therapeutic interventional clinical trials as well as observational clinical studies. The majority of clinical studies supported by NIA’s ERP are performed at large academic institutions, including NIA’s Alzheimer’s Disease Research Centers (ADRCs) and the Alzheimer’s Clinical Trials Consortium (ACTC), as well as by small businesses and biotech companies.

The successful deployment of the NIA Clinical Research Operations & Management System (CROMS) v1.0 by the NIA marked a significant stride in addressing the urgent need for a sophisticated institute-wide informatics system. The NIA CROMS is an NIA-wide system application is comprised of multiple components and supports the clinical research information needs of the NIA by providing comprehensive administrative and scientific information management for each NIA supported clinical study. This complex and expansive system plays a critical role in the real-time collection, tracking, reporting, and management of the Institute’s diverse clinical research data and portfolio. The system seamlessly integrates with other NIH databases and systems, such as the Human Subjects System (HSS), and has capabilities for seamless interoperability with external databases, including those belonging to grantees and clinical sites. As CROMS evolves, there is a clear recognition of the system's intricate nature and the specialized knowledge required to navigate NIA's comprehensive research portfolio and its network of grantees.

Given the scale of NIA’s portfolio, the CROMS is instrumental in capturing comprehensive funding information for over 3,000 active grants. Additionally, it plays a pivotal role in actively managing the recruitment and retention aspects for more than 1,000 clinical trials. There is a discernible need to augment its breadth and depth, underscoring the necessity for a partnership that can navigate the complexities of such a large-scale NIA-wide system. The NIA is poised to collaborate with entities that possess a deep understanding of these dynamics, and the capability to sustain and advance this crucial infrastructure, ensuring the continuous and efficient management of its expanding research landscape.

Additional information related to NIA’s extramural clinical research programs is available on the NIA website at the following address: https://www.nia.nih.gov/research/research-divisions-contacts.

Information about NIA’s extramural grants and training policies and procedures can be found at:

https://www.nia.nih.gov/research/grants-funding.

3. Objective NIA’s objective is to continue to design, develop, maintain, and operate a unified and integrated Clinical Research Operations & Management System (CROMS) that supports the unique data and clinical research process needs of NIA’s ERP and provides an institute-wide informatics capability to track, report and manage NIA’s clinical research data, activities, and portfolio in real time.

Specific objectives include, but are not limited to:

- Maintain and enhance, as requested, a state-of-art, high value software solution in a timely and cost-effective manner.

- Evaluate, plan, and adapt new components/capabilities in response to changing business strategies, policy, and regulatory changes.

- Enable OCR to obtain high quality technical expertise at a reasonable cost.

- Respond to wide range of in-scope business needs.

- Provide continual process and service delivery improvements.

- Support the system development lifecycle including investigating software requests, gathering and analyzing requirements, designing solutions, developing and coding software, configuring COTS components, documenting system changes, platform and application deployment, and disposition of system as appropriate.

4. Scope The scope of this procurement is to continue to develop, deploy, and maintain the expansion of the integrated clinical research operations and management system (CROMS) for NIA in accordance with https://www.nia.nih.gov/research/research-divisions-contacts https://www.nia.nih.gov/research/grants-funding regulated clinical research requirement set forth by applicable health authorities.

Specific contract activities shall include, but are not limited to, system development, deployment, maintenance, business intelligence and analytics, identity and access management, document and roster management, project management support, training and training documentation, Helpdesk and user support, security, security assessment and authorization support, data entry, data management, computer system validation, and integration to support key business areas surrounding NIA’s clinical research portfolio.

4.1 Complexity

The NIA CROMS currently maintains over 7 different modules or components. These components range from large efforts that have several staff years invested in their development, to smaller modules that have been developed with less effort. CROMS staff are actively involved in development and maintenance of at least 2 to 3 of these applications simultaneously. At any time, a bug, vulnerability, or new requirement may materialize for any of the components, including those not currently being worked on. When an unexpected need arises, the contractor staff must, at Government direction, evaluate the need and address it appropriately. This complex, rapidly changing environment requires staff flexibility and project agility.

4.2 Innovation and Reach Back

The Government is committed to ongoing innovation in software development and maintenance. Of interest are approaches that:

• Shorten lead times from the time a requirement is identified until it is deployed and in use.

• Produce higher quality solutions that more accurately meet NIA’s business requirements.

• Improve compliance with requirements such as security and governance.

• Result in fewer and shorter outages and downtime.

A critical success factor of innovation at NIA will be the contractor’s commitment to staff development and change management. The government can provide the organizational leadership, but the contractor must share a commitment to change management. The Government understands organizational improvement is a constant pursuit of excellence that requires regular evaluation, measurement, and improvement. Therefore, the contractor’s commitment to change must be ongoing and part of the culture of the team.

The dynamic nature of NIA’s mission demands innovative solutions to new problems. The contractor should provide a reach back capability that brings innovative technological solutions to bear. Contractor developed solutions for other government agencies (i.e., other NIH ICs) and or commercial clients should be leveraged at NIA. The contractor should have a process or technique for “reaching back” to corporate resources and leveraging those resources for NIA’s benefit.

5. Specific Tasks Independently, and not as an agent of the Government, the Contractor shall exert its best efforts to furnish all necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government under the terms and conditions of this contract as needed to perform the work set forth below.

The contractor will cooperate with NIA to ensure that the objectives, scope, deliverables, schedule, and roles and responsibilities are in accordance with a tailored form of HHS Enterprise Performance Life Cycle (EPLC) methodology.

The NIA CROMS (and associated component systems) must meet Government IT security requirements.

The NIA CROMS must meet NIA’s informational needs and ensure compatibility with relevant NIA standards.

The functional area tasks are listed in general terms and the Government will work closely with the contractor to provide the necessary reference documents, format, and information needed for the tasks or document packages. The contractor shall provide knowledgeable personnel in support of this contract and work as a partner with the Government to meet the performance requirements.

5.1 Task 1. Project Management and Key Personnel

NIA requires project oversight to help ensure successful completion of the project tasks.

The Contractor shall develop and implement a Project Management Plan for the overall management, quality control, integration and coordination of all contract activities, including the management and coordination of activities carried out under subcontracts, if any. The plan must detail a description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, reporting, and oversight of contract requirements. The Contractor shall provide and update the Project Management Plan, as requested and approved by the COR, for the effective overall management, staffing (including succession planning), budgeting and tracking of contract activities, inclusive of subcontractors.

The Contractor shall provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all projects carried out under this contract, and effective communications with the Contracting Officer’s Representative (COR). At the direction of the COR, the Contractor shall work with the key subject matter experts in each Division to meet the needs of the Division.

The Contractor shall provide a Project Director with responsibility for overall project management and communications, tracking performance and cost, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines, including projects undertaken by subcontractors.

The Contractor shall provide a Program Manager who will be responsible for overall management, integration, and coordination of all contract activities, including the management and coordination of activities carried out under subcontracts, if any. The management methodology should be based on software engineering industry best practices (e.g., Agile Scrum and Develops) which should be described in the proposal.

The Contractor shall provide key personnel with relevant individual education, training, expertise, experience, qualifications required for the successful completion of contract requirements. Staffing levels must provide adequate capability to accommodate planned and unplanned personnel absences and include succession planning, while maintaining CROMS services at all times. The contractor shall provide and maintain an accurate organizational chart of all staff defining roles and responsibilities as well as proposed level of effort.

The Contractor shall ensure it has the most current and accurate information and certifications regarding the required and evolving clinical research laws, regulations, policies, and guidelines (Federal-wide, NIH, and NIA-specific) related to clinical research, and Good Clinical Practice (GCP).

The Contractor shall provide documentation that all contractor personnel have appropriate certification for GCP and Human Subjects Protection (HSP) prior to beginning work on the contract.

Key Personnel Experience and Skills:

The following skills are highly desirable for the proposed key personnel:

• Demonstrated experience in managing projects of similar scope and magnitude, specifically clinical research information systems development.

• Excellent verbal and written communication skills.

• Experience and successful track record of working with NIH ICs in the area of informatics and clinical research information system design and development, similar in-scope and size as NIA

CROMS.

• Demonstrated experience working with NIA (NIA Leadership, Program Staff, NIA Offices of the Director) and in the area of clinical research management is desirable.

• Knowledge and expertise of emerging information technologies, computer system validation, database management systems, and clinical informatics, and

• Knowledge and understanding of the clinical research, scientific agenda, and business processes of the NIA, as well as knowledge of AD/ADRD, dementia, and aging research domains.

Meetings and Travel:

All travel and meeting attendance by contractor staff must be reviewed and approved in advance by the COR or their designee.

• Contract Initiation Meeting: Within 30 calendar days after the effective date of the contract, participate in a Contract Initiation Meeting with the COR, the Contracting Officer and other NIA personnel designated by the COR, to be held in the Rockville, MD area. The purpose of the Contract Initiation Meeting shall be to meet key personnel, orient the Contractor to NIA contract procedures, as well as the statement of work.

• As requested by the COR, the contractor shall participate in any annual meeting(s) of the contracts and grants supported by the contract.

• Ad hoc meetings may be held at the discretion of the COR

Project Status Meeting:

• At the direction of the COR or their designee, participate in weekly meetings with the COR, and/or designees, to review the status of current and planned contract activities and assignments, current and anticipated difficulties and their resolutions.

• Participate in monthly meetings with the COR and key subject matter experts in each Division to review the status of current and planned cooperative activities, current and anticipated difficulties and their resolutions.

• Prepare and distribute meeting agendas and background materials in advance of meetings.

• Prepare and distribute brief summaries of major decisions, recommendations and action/follow-up items resulting from monthly meetings.

In-person Contractor Site Visits:

At a minimum, one site visit, to be held at the Contractor’s facility, shall be conducted each year to review contract progress, policies and procedures, discuss identified problems and deficiencies and their resolution, and review future plans. Participants in annual site visits may include the Contracting Officer, COR, other NIA staff, and key Contractor and subcontractor personnel or designees. In collaboration with the COR, the Contractor shall be responsible for planning and conducting site visits, including:

• preparation and distribution of site visit agendas and background materials;

• preparation and presentation of data and other information on contract activities; and

• submit to the COR a written summary of major outcomes, action items, decisions and recommendations resulting from each site visit.

At any time during the contract period of performance the COR and the Contracting Officer may elect to conduct additional site visits to the Contractor’s facilities or request Contractor participation in contract reverse site visits which will be held in the Rockville, MD area, either in place of, or in addition to, an annual site visit at the Contractor’s location. In such instances, the Contractor shall be notified in advance and shall be provided with the agenda and items for discussion.

The contractor must ensure that Contractor staff are available to meet with the COR or designees at the offices of NIA in Rockville, Maryland with short notice for urgent situations.

5.2 Task 2. Business Modeling Activities

The contractor shall develop and maintain a repository of business models for “As-is” and “To-Be” clinical research management processes within the NIA. The scope of business models to be stored and maintained shall span, at a minimum, the following activities and artifacts:

• Business Modeling of “As-is” and “To-be” workflow processes

• Business Systems Modernization

• CROMS backlog of User Stories

• System Configuration and Change Management process flow

• Enterprise Architecture

• Automation of Administrative and Clinical Processes

5.3 Task 3. Architect, Design, Development, and Maintenance

Activities

The contractor shall assume responsibility for the maintenance and enhancement of NIA CROMS modules currently in operation, as well as the continued development and refinement of components currently under development. New components, whether entirely new modules or significant updates to existing ones, shall be developed based on NIA’s evolving research and operational needs. The contractor shall ensure that all enhancements integrate seamlessly with the existing system architecture and support CROMS’ overall functionality and objectives. Priority areas for development and enhancement will be identified by the NIA COR.

The contractor shall work with NIH and the STRIDES team to migrate NIA CROMS to the NIH Cloud (STRIDES). This includes setting up the Azure subscription, configuring AD Security Groups, migrating pipelines, DevOps items, and data, and configuring environments. The contractor will ensure seamless integration, restore data, test services, and deprecate the existing NIA CROMS tenant.

Components/features to be developed or enhance, and deployed shall include, but not limited to the following:

• Clinical Trial Monitoring

• Study Recruitment, Retention, and Attrition

• System to system API Management

• User Training

• Digital Content Management and Communications (e.g., clinical)

• Data and Safety Monitoring Board (DSMB) / Independent Safety Monitor (ISM)

• Grants Portfolio Management

• Congressional Reporting and Dissemination of Data

• Corrective Action Plan.

The contractor shall propose enhancements and adaptations to the existing system to ensure that the following NIA needs are addressed through system capabilities:

• Operationally support both clinical trials and population studies,

• Implement CDISC standards (SDTM),

• Continue to use standardized definitions across NIA CROMS (e.g., definition for enrollment, study status),

• Consistently enforce standards for data and document management across divisions,

• Uniquely identify sites, NIA staff, and key study personnel,

• Collect study enrollment and demographic data for enrollees in system from 1000+ grantees who submit data directly into system,

• Maintain granularity of enrollment data from collection through reporting,

• Maintaining DSMB metadata for each study,

• Store study documents and maintains records to ensure version control, including clinical documents (e.g., protocols, consent forms), and business documents (e.g., DSMB members’ CV and Conflict of Interest [COI] documents, DSMB charters),

• Maintain a central roster of PIs and site contacts,

• Maintain a roster of DMSB members for NIA clinical studies,

• Maintain a standardized repository of all interventions used with NIA clinical research studies,

• Provide external access for PI to view and utilize CROMS data,

• Include and update clinical study costs and funding information,

• Integrate the NIA CROMS with NIH Cloud,

• Facilitate exchange of data with NIH systems behind the NIH firewall (e.g., Human Subjects

System (HSS) and clinicaltrials.gov),

• Resolve HSS data challenges (incorrect data submitted, duplicative data submitted, data binned inappropriately),

• Facilitate automated data exchange into CROMS from external clinical databases providers (e.g., RedCAP),

• Incorporate Neighborhood Atlas and Geographic Information System (GIS) data in CROMS and incorporate into existing reports to refine performance evaluations,

• Integrate AI and Gen AI Technologies as allowed within NIH policies; including: Design and develop AI and Gen AI components within the NIA CROMS to enhance data processing, predictive analytics, and decision-making capabilities, including automating data management, data categorization and enabling real-time study monitoring and participant engagement insights.

5.4 Task 4. Data Population, Management, Governance, and Quality Control

Migrate data from legacy systems and/or collaborator systems into the NIA CROMS. The NIA CROMS contractor shall work closely with the Divisions and their contractors to review, curate and load data into NIA CROMS.

Contractor shall work with NIA OCR to manage and maintain shared data across NIA Divisions and Offices. Working in collaboration with the NIA staff and its stakeholders the Contractor shall provide data management support activities for NIA CROMS such as:

• Abstract key protocol information and maintain protocol document library in the NIA CROMS,

• Maintain protocol status and milestones throughout their lifecycle in the NIA CROMS,

• Maintain a standardized list of study interventions, tests, and procedures used on NIA protocols,

• Track the eligibility criteria for each study,

• Maintain information about organizations and people involved in NIA-funded and/or sponsored clinical research, and their institution and contact information,

• Work with NIA staff to verify and update abstracted protocol data,

• Work with NIA stakeholders and the NIA CROMS Helpdesk team to resolve data issues,

• Support the NIA staff and their stakeholders in developing canned and or ad hoc reports using

CROMS,

• Work with the NIA staff and their stakeholders in setting up workflow associated with data population (to include data and safety as well as grants management information) in the NIA

CROMS,

• Work with the NIA COR as necessary to identify, resolve, manage, and track data quality and currency issues,

• Enhance / Automate QC activities and data quality checks,

• Provide ad hoc data management and support tasks as required by NIA staff and stakeholders,

• Develop and maintain standard operating procedures for abstracting and maintaining information within the NIA CROMS (to include implementation of IT and clinical standards),

• Participate in meetings and working groups across NIA to discuss the impact of decisions on

CROMS processes and data, as well as the ability and effort needed for CROMS to support pending and future business decisions,

• Participate in meetings with NIA Leadership and Program Staff to present and explain data observed in the system, and/or explain how observed data are sourced, derived, calculated, reported, and maintained,

• Participate in other activities such as quality assurance and control, and related meetings at NIA as required.

5.5 Task 5. NIA CROMS Computer System Compliance and Validation The Contractor shall provide system testing services and computer system validation services as appropriate for all NIA software and shall use processes that conform to NIST and Federal IT requirements and be implemented on FedRAMP approved infrastructure. In addition, the Contractor will comply with CROMS Quality Management System based on GAMP 5.

The Contractor shall maintain compliance with prevailing Federal Risk and Authorization Management Program (FedRAMP) standards through annual Third-Party Assessment Organization (3PAO) audits, as well as updating policies and procedures to be compliant with evolving standards.

The Contractor shall maintain compliance with Federal Information Security Management Act (FISMA) moderate requirements by regular and ad hoc updates to address new threats, changes in technology, and evolving federal requirements.

The Contractor shall maintain compliance with FDA regulations including 21 CFR Part 11 compliance for regulated modules of CROMS (e.g., DSMB Module), as well as updating policies and procedures to be compliant with evolving regulations.

For modules that need to be 21 CFR Part 11 compliant, the Contractor shall provide documented evidence of compliance with regulatory requirements including 21 CFR Part 11, ICH E6 R2, and GAMP 5 (or similar risk-based framework). This package must be provided for the initial deployment and for any subsequent upgrades. The package must include:

• Documentation of System features supporting 21 CFR Part 11, particularly electronic signatures.

• Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualifications

(PQ)artifacts such as IQ plan, OQ Plan, PQ Plan, executed scripts, and summary reports.

• Any Standard Operation Procedures (SOPs) referenced by the qualification plans.

The Contractor shall develop new modules and features and perform necessary activities to maintain a validated system in compliance with FDA and ICH requirements. Contractor shall develop processes and procedures to support and maintain regulatory compliance requirements, as well as respond to validation findings and take corrective actions. The Contractor shall support health authority inspections.

The Contractor is responsible for a variety of Cyber-security activities and tasks, including but not limited to:

• Analyzing security needs, risks and requirements of the CROMS.

• Maintenance of an Information Security Plan

• Recommending and implementing security features within CROMS, as necessary, to adhere to

Federal, HHS, NIH, and NIA security requirements.

• Ensuring the entire systems is FISMA compliant.

• Supporting FISMA security processes including obtaining and maintaining Authority to Operate

(ATO) status for the CROMS and resolving Program of Milestones and Actions (POAMs)

5.6 Task 6. Help Desk, Training, and Documentation Support

The Contractor is required to establish and maintain a comprehensive Helpdesk service for the NIA CROMS, catering to inquiries from NIA staff, other affiliated personnel, and external researchers along with their teams or institutions. This Helpdesk is not only tasked with addressing standard IT-related queries, such as login difficulties or technical glitches, but also extends its support to more nuanced business process issues. This includes providing detailed guidance on data elements within CROMS – for instance, clarifying what should be entered in specific fields like 'actual enrollment start date,' and addressing unique situations in grantee studies, such as how to proceed when a study does not involve randomization.

Furthermore, under the direction of the COR, the Contractor will compile and submit reports and analytics detailing the nature and frequency of the issues addressed. The Helpdesk will offer multi-tiered support, encompassing Level 1, Level 2, and Level 3 assistance, to ensure comprehensive resolution of both IT and business process challenges encountered by users of the NIA CROMS.

The Helpdesk shall respond to all responses in a clear, concise and timely manner. The Helpdesk must have the capability to correspond via telephone, e-mail, or video conference (e.g., Teams, Zoom). The Helpdesk shall track all requests until completed to the requestor's satisfaction. The requestor shall be periodically notified regarding the status of their request and provided the ability to submit feedback regarding the system.

At the direction of the COR, the Contractor shall ensure the development of training material and documentation as well as related standard operation procedures (SOPs) to assist the users of the NIA CROMS in successfully executing their interactions with the system. The Contractor shall provide suggestions to the COR regarding the type of documents and tools needed by NIA CROMS users, and will generate those documents and tools authorized and approved by the COR. The Contractor shall provide updated end-user training and documentation whenever there are new or significant changes to the system functionality. The Contractor shall also train NIA CROMS users and contractors when new NIA CROMS components are rolled out.

5.7 Task 7. NIA CROMS System Administration, Operations, and

Maintenance Support

It is critical that the proper levels of performance and integrity of the CROMS system are maintained, primarily through operations maintenance and other support activities. The contractor shall perform all periodic operational tasks required to maintain the proper level of performance and integrity of the entire NIA CROMS components.

The Contractor shall provide ongoing system administration and maintenance support of the NIA CROMS, including, but not limited to, software maintenance and user support. Specific requirements include:

• Working with NIA to update and maintain infrastructure and tools, and establish and maintain system access,

• Working with NIA to deploy new CROMS releases and patches,

• Facilitating creation of user accounts working with NIA,

• Granting privileges to NIA CROMS users to access various CROMS components,

• Keeping all customers informed of situations that may affect performance of the system, and

• Supporting ad hoc report requests and resolving technical queries from NIA and their collaborators.

5.8 Task 8. NIA-Wide Reporting and Analytics Development

The purpose of this task is to continue development of NIA-wide reporting and analytics system to support the NIA Director’s strategic goals to enable research and decision making. The solution shall support data ingest, data exploration and data analyses to help discover trends, issues and facilitate application of existing resources (e.g., increasing enrollment diversity in NIA’s clinical trials) to advance research related to diseases (e.g., Alzheimer's disease and related dementias research).

Institutional Accountability for Research:

• Quickly and accurately analyze enrollment data in response to queries from NIA oversight bodies about NIA’s research portfolio performance,

• Access a single source that provides an enterprise view of the full NIA clinical research portfolio in near real-time,

• Answer questions about study trends, or progress in one or more targets, and what has been learned.

• Access a single source that provides a near real-time enterprise view of:

o The full NIA clinical research portfolio, o A single Division’s research portfolio, o A single Program Officer’s (PO) or Grant Management’s (GM) research portfolio, Systematically evaluate/understand:

• Which sites are top performing,

• Success by study, identify attributes for best practices,

• Capacity at sites,

• Demonstrate the diversity of the research targets,

• Allows for real-time data analysis to generate standard and custom reports (at trial, site, and overall portfolio levels),

• Able to connect grant awards and expenditures with clinical study awards and progress

• Develop an interface/experience to quickly query across CROMS for integrated grant, study, site, and participant-level data which is compliant with the NIH and NIA policies and guidance on Artificial Intelligence. For more information, please refer to Artificial Intelligence at NIA and https://osp.od.nih.gov/policies/artificial-intelligence/.

o AI-Powered Data Insights - Implement AI-driven analytics tools to automate the generation of real-time performance reports, flagging underperforming clinical studies and enabling early intervention strategies to enhance recruitment diversity and trial retention rates.

o Gen AI for Trend Analysis and Decision Support - Leverage generative AI models to facilitate advanced trend analysis across NIA’s clinical research portfolio, providing insights into participant demographics, study outcomes, and optimizing resource allocation in line with strategic research goals.

• Easily analyze detailed demographic and inclusion data,

• Understand why participants are lost to follow-up,

• Provide quarterly and yearly trend analyses for increase and decrease in various targets (e.g., https://nih.sharepoint.com/sites/NIA-ITB/ETWG/SitePages/AI-Introduction.aspx?xsdata=MDV8MDJ8c21pdGhzQG1haWwubmloLmdvdnxmOGE4NjFmMjM3NDk0ZjkxMzRkZjA4ZGNhMWI1ZWVhZXwxNGI3NzU3ODk3NzM0MmQ1ODUwNzI1MWNhMmRjMmIwNnwwfDB8NjM4NTYzMDUwNTQyNjEwNTU5fFVua25vd258VFdGcGJHWnNiM2Q4ZXlKV0lqb2lNQzR3TGpBd01EQWlMQ0pRSWpvaVYybHVNeklpTENKQlRpSTZJazFoYVd3aUxDSlhWQ0k2TW4wPXwwfHx8&sdata=V05jUWFHNE8zMXJjaDd4SEFmUHVRalpMQnlJRHBzR3dqSjlEdU9ENTdRST0%3d https://osp.od.nih.gov/policies/artificial-intelligence/ diversity, attrition rate, CAPs required),

• Track and report grantee performance opening and closing studies per the approved plan,

• Generate data insights to improve recruitment and retention and reduce attrition,

• Generate data insights to optimize participant diversity,

• Allow NIA Program staff to create custom reports for any data element in CROMS that can be saved, shared, and delivered by email at a defined time and frequency,

• Provide automated triggers to flag underperforming studies that initiate and track corrective action plans (CAPs) in the system,

• Assist in identifying potential safety trends.

Operational Portfolio Management - Support POs and Grant Management Specialists (GMSs) with monitoring and tracking of grant information, including but not limited to:

• Alert Program Officer (PO) when a Notice of Award (NOA) is issued for a grant in their portfolio,

• Tracking grant information and restrictions in their portfolios,

• View information related to enrollment goals in real-time,

• Track individual site performance in multi-site studies,

• Track screening, retention, and attrition,

• Expand current Program Staff dashboards and develop additional dashboards for NIA

Leadership, as well as key offices within the OD

• Ability for NIA Staff to add or remove widgets/visualizations from a library of tools thereby creating customized/personalized dashboards of CROMS data to support individual portfolio needs.

6. Transition

6.1 Initial Transition

In the event transition between contractors is required, the Contractor shall work with the COR and incumbent contractor to ensure an orderly, secure, and efficient transition of contract-related materials and activities from the successor contractor or from the Government. Specifically, the Contractor shall:

• Within 5 business days of the contract effective date, the COR will provide the

Contractor with the incumbent’s Final Transition Plan, which will specify transition requirements and processes.

• Within 15 calendar days of the effective date of the contract, the Contractor shall submit to the COR and Contracting Officer for approval, a Draft Initial Transition Plan and timeline for the transition of activities and contract-related materials from the current contractor, and the activities required for having the Contractor’s facility ready for contract initiation,

• Upon COR and Contracting Officer approval of the Draft Initial Transition Plan, implement and complete the transition within the first 30-45 calendars days following the effective date of the contract,

• Participate in a series of joint meetings with the incumbent contractor, the COR or designees to: (i) review the status of all services being provided or expected to be provided during the first 3 months of the contract period of performance; (ii) discuss any contract deficiencies and problems identified over the past year, corrective/remedial actions needed, and the status of their implementation; (iii) review project management procedures and issues, including process changes with respect to planning and implementing contract requirements, developing performance measures and assessing the quality of services provided, and contract staffing and turnover; and (iv) discuss other transition topics as needed.

6.2 Final Transition

The Contractor shall make available to a successor contractor all programs, documents, other contract-related materials, as well as any Government Furnished Equipment and Software. These materials shall be organized and catalogued in sufficient detail to support an orderly transition to the successor contractor.

The Contractor shall prepare a transition plan to be implemented within 30-45 business days before the end of the contract period of performance or within 5 days notification that NIA intends to terminate the contract that details access to the NIA CROMS, accumulated data and software tools. The plan shall include, but not be limited to: a comprehensive inventory of all the data, websites, software tools, and technology developed, accumulated, and distributed during the contract’s performance as well as a list containing detailed descriptions of any process documentation developed during the contract’s performance. The plan shall also include the recommended steps necessary for a successful transition of cloud IaaS, PaaS and CROMS software to a subsequent contractor in order to sustain the activities provided for in the contract.

• Final Transition Plan: Within 6 months prior to the completion date of the contract, submit the Final Transition Plan, revised as necessary to accommodate COR comments.

• Maintain full operational capacity until the completion date of the contract.

All performance requirements of the contract will remain in effect until contract term as defined expires. At no time and under no circumstances will the contractor withhold or render inaccessible any NIA documents or data.

7. Period of Performance The contract period of performance (POP) shall be for one (1) Base Year with four (4), one-year (1-year) Options Years (OY) periods. The Base Year POP will be from July 1, 2025 through June 30, 2026. The OY POPs will be exercised as appropriate and will be dependent upon Government availability of funds.

Period of Performance Start Date End Date Base Year (BY) July 1, 2025 June 30, 2026 Option Year One (OY-1) July 1, 2026 June 30, 2027 Option Year Two (OY-2) July 1, 2027 June 30, 2028 Option Year Three (OY-3) July 1, 2028 June 30, 2029 Option Year Four (OY-4) July 1, 2029 June 30, 2030

8. Deliverables/Delivery Schedule

8.1 Deliverable Inspection and Acceptance Criteria

Final inspection and acceptance of all work performed, reports and other deliverables will be performed at the place of delivery by the COR or the COR’s designated Federal Technical Point of Contact (TPOC).

8.2 Key Deliverables

Key deliverables to NIA are summarized in the following table.

Task # Deliverable Schedule

5.1 Project Management Plan Draft: 15 calendar days from award, Final: 15 calendar days from approval of Draft

5.1 Invoice (Labor category, current hours, rate amount and cumulative metrics, forecast for remaining months)

Monthly, Draft: 15 calendar days from award, Final: 15 calendar days from approval of Draft NLT 10th calendar day

5.1 Final Status Report (Task actuals with

travel, ODC, indirect costs, grand total task area, total funding, total ceiling)

Monthly, NLT 15th calendar day

5.1 Other documentation As requested

5.1 Key Personnel documentation 30 calendar days after award

5.1 Organizational chart 30 calendar days after award, update as necessary

5.1 Personnel Transition-In Plan Deliver with proposal

5.1 Personnel Transition-Out Plan As required

5.1 Resource identification and budget

projection plan Draft: 15 calendar days from award, Final: 15 calendar days from approval of Draft

5.1 Final Staffing Plan 30 calendar days after award

5.1 Staffing Matrix (On-site contract

personnel document with category / billing rate by task area)

60 calendar days after delivery of Position Description. Updated monthly.

5.2 Business models for “As-is” and “To-Be” Dependent on Individual Project Schedule

5.3 EPLC Documentation (Concept, Project

Charters, Requirements, Design, Test Plans, Job Aids, etc.)

Dependent on Individual Project Schedule

5.3 Change Control and Configuration

Management Documentation

Dependent on Individual Project Schedule

5.3 Incident and Resolution Report Within 2 business days of resolution

5.3 System Upgrade Documentation Dependent on Individual Project Schedule

5.3 Projects Investigation Documentation Dependent on Individual Project Schedule

5.3 Project Development Documentation Dependent on Individual Project Schedule

5.5 Evidence of compliance with regulatory

requirements As required

5.6 End-user training, training materials, and Dependent on Individual Project Schedule documentation

5.8 Tracking and Analytic Reports Dependent on Individual Project Schedule

6.1 Initial Transition Plan Draft: 15 calendar days from award

Implementation: 30-45 calendar days from award

6.2 Final Transition Plan Draft: 6 months prior to the completion date of the contract Implementation: 30-45 calendar days prior to the end of contract period of performance or within 5 days of notification that NIA intends to terminate the contract.

9. Incentives Performance of these objectives and tasks will be annotated in the Contractor Performance Assessment Report System (CPARS) Rating. Meeting the program objectives and providing support services above and beyond the standard requirements will be noted in a positive statement for the contractor’s past performance.

10. Optional Tasks

The following section provides an outline of potential activities and tasks and are not meant as a proscriptive formula. The Government’s intent is to work closely with the Contractor to develop a sound technical plan and implement with minimal disruption to the critical operation and functioning of the CROMS system. Sections 10.1 and 10.2 describe two optional components that could be, either one or both, be exercised during the CROMS upcoming contract.

10.1 Protocol Management component (Optional Task)

The NIA CROMS currently supports the managing of clinical research grants funded by NIA. However, the institute wants to explore and potentially, create a protocol management component. The purpose of the protocol management component will be to populate, organize, and analyze the data by clinical study and linked to the grant information.

This component will allow the collection of a full array of clinical trial metadata such as condition under study, study intervention, safety oversight information, and eligibility criteria. This component will also include a document repository for study documentations (e.g., protocol, consent, safety management plan) as well as standardized intervention and condition libraries.

The information will be collected and organized in such a way that it will easily allow the transfer of protocol information to and from clinicaltrials.gov. Furthermore, it will allow NIA to automatically pull any study/grant related publications from …. and link them to each protocol.

10.2 Safety Management Component (Optional Task)

The following section provide an outline of potential activities and tasks and are not meant as a proscriptive formula. The Government’s intent is to work closely with the Contractor to develop a sound technical plan and implement with minimal disruption to the critical operation and functioning of the CROMS system.

As per FDA guidance, it is essential that NIA has a systematic approach to safety surveillance for studies that it funds and that it adequately assesses the risks associated with the interventions that being developed or tested with NIA funding. Thus, NIA wants to explore, and potentially, create a safety management component within the NIA CROMS to ensure that NIA is able to review, evaluate, and manage safety data collected from its entire clinical research database.

This component will provide the ability for NIA centrally collect and analyze trends in a variety of ways (e.g., by intervention, intervention class, and condition). In addition, this component will creations of visualization to be able to easily detect safety signals. This component will also serve as an archival repository for SAE reports that occur on NIA funded research.

This component will be collecting and archiving SAE information from NIA funded trials at the end of the study. The collected information consistent with ICH E2B(R3) Individual Case Safety Report (ICSR) Specification, MedDRA coding, and any other requirement as determined by COR.

10.3 Expand and Adopt CROMS Platform for Other NIH Institutes, Centers, and Offices (ICOs) (Optional Task)

CROMS has been reviewed by several other NIH ICOs with at least one ICO expressing interest in adopting CROMS for the management of their clinical trial portfolio(s). This optional task would be exercised if another NIH ICO chooses to invest funds to expand the CROMS platform and tailor the system’s functionality to address the ICO’s clinical research management processes and policies. The intent would be to adopt functionalities “as is” to the degree possible and minimize special adaptions that will increase costs. It is anticipated that one ICO at a minimum will exercise this optional task.