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,