NCI Oncology Clinical Trial System, Management and Support

Type of Notice: This is a Small Businesses Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to determine (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; women-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 response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code for this acquisition is 541512 Computer Systems Design Services. The small business size standard is $34M. Background: The Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI), sponsors and coordinates a broad portfolio of clinical trials evaluating cancer treatments, ranging from early-phase studies to large-scale multi-site trials conducted through national research networks. CTEP relies on a suite of integrated enterprise applications to support protocol and study management, study activation, investigational agent/drug management, safety reporting, regulatory workflows, and data sharing and reporting across a large and diverse community of investigators, sites, and research networks. CTEP s Enterprise System (CTEP-ESYS) is NCI s enterprise system environment for supporting the conduct, oversight, and evaluation of NCI-sponsored oncology clinical trials. It provides integrated applications, data repositories, interfaces, and services that support protocol development, study administration, regulatory oversight, user and site credentialing, investigational agent management, safety reporting, data exchange, and operational decision-making across the clinical trials enterprise. Purpose and Objectives: The goal of this acquisition is to identify qualified small business sources capable of providing enterprise-level informatics, application development, modernization, and operational support for CTEP-ESYS environment. The requirement supports complex biomedical, clinical research, healthcare, regulatory, and clinical trial operations, and may include, but is not limited to: Enterprise application operations, maintenance, and enhancement for large-scale, mission-critical enterprise applications and integrated application suites; Custom application development, re-engineering, modernization, and migration, including cloud-based or cloud-first modernization, while maintaining continuity of operations; Clinical trial and biomedical informatics support, including systems for protocol/study management, study activation, trial oversight, investigational agent/drug management, safety reporting, regulatory workflows, and clinical research data management; System integration, interoperability, and data exchange across Government and partner environments, including APIs, interfaces, data pipelines, reporting workflows, and data quality controls; Data management, reporting, analytics, automation, and AI/ML capabilities, including AI-assisted data extraction, classification, summarization, workflow automation, and decision-support tools where outputs support human review rather than replace Government or clinical decision-making; AI-assisted workflow support and governance, including data readiness assessment, model/tool evaluation, validation, monitoring, documentation, and governance of AI/ML-related activities Security, privacy, and compliance support for Federal information systems, including FISMA/NIST-based controls, identity and access management, vulnerability management, ATO support, audit logging, cloud security, backup/disaster recovery, and continuous monitoring; and User support, stakeholder coordination, and program management, including help desk support, stakeholder coordination, deliverables management, staffing, performance tracking, and surge support These systems support mission-critical, uninterrupted clinical trial operations across multiple trial phases, research networks, participating sites, and investigators, and require modernization of legacy components without disruption to active operations. CTEP-Specific Technical Considerations: Respondents should also be prepared to address their ability to support: A suite of integrated custom applications rather than a single standalone system Mission-critical operations, maintenance, enhancement, modernization, and integration support Clinical trial workflows involving protocol/study management, study activation, trial oversight, investigational agent management, safety reporting, regulatory support, data sharing, and reporting Modernization of legacy components while maintaining uninterrupted support for active clinical trial operations Cloud modernization, application migration, DevSecOps, automated testing, release management, and production support Integration with multiple internal and external systems and partners AI-assisted or advanced analytical capabilities within existing enterprise workflows, such as protocol information extraction, workflow automation, reporting support, and decision-support functions Controlled evaluation and implementation of AI/ML or automation use cases with appropriate validation, documentation, security, data quality, traceability, and human oversight Enterprise IT operations, maintenance, and production support for custom application environments, including incident management, change management, release management, and service-level tracking Agile software development, systems analysis, requirements management, testing, configuration management, and documentation for custom application portfolios Database administration, data engineering, data repositories, reporting, dashboards, and business intelligence support API development, interface management, data exchange, and integration with internal Government systems and external partner systems Section 508, usability, and user experience considerations for systems used by Government, contractor, investigator, and research site users. Note: Please only respond to this notice if you are capable of addressing the full range of capability areas described above. Project Requirements: A copy of the draft Statement of Work (SOW) pertaining to this requirement, which is subject to revision, is attached to this notice. Anticipated Period of Performance: The anticipated period of performance, inclusive of options, for this proposed acquisition is July 1, 2027 June 30, 2032. The Government anticipates making a single award, which may be issued as a contract or task order depending on the final acquisition strategy. Capability Statement/Information Sought: Small businesses possessing experience and demonstrated capability to accomplish the requirements described above are requested to submit a capability statement addressing the following: Capability and Experience Describe your experience supporting enterprise systems, informatics, or application support systems for biomedical research, clinical trials, healthcare, regulatory, or scientific programs. Clinical Trial / Biomedical Informatics Experience Describe your experience supporting systems involving protocol/study management, safety reporting, regulatory workflows, investigational agent/drug management, or clinical research data management. Application Development and Modernization Describe your experience maintaining, enhancing, modernizing, and migrating custom applications in a complex multi-system environment while maintaining production operations. Interoperability and Data Exchange Describe your experience integrating systems across multiple organizations, including APIs, data exchange, reporting, dashboards, data pipelines, and data quality controls. Advanced Analytics, Automation, and AI/ML Describe your experience developing, integrating, or supporting advanced analytics, automation, or AI-assisted tools in Federal, biomedical, healthcare, clinical research, or regulated environments. AI Use Case Identification and Governance Describe how you would identify, evaluate, validate, monitor, document, and govern AI-assisted capabilities used to support operational or decision-support workflows. Security and Compliance Describe your experience supporting Federal security requirements, including FISMA/NIST-based controls, ATO support, vulnerability remediation, identity/access management, audit logging, cloud security, and systems handling sensitive Government or research data. Small Business Capability Identify your business size and socioeconomic status under the anticipated NAICS code, and indicate whether your company could perform as a prime contractor or subcontractor. Commercial vs. Non-Commercial Availability Identify whether commercial products…