The FDA is preparing to release the Sentinel 3.0 System contract—an estimated $310 million procurement that will sustain and expand FDA’s national electronic system for monitoring medical product safety. This opportunity builds on the 2007 congressional mandate and the agency’s long-term efforts to strengthen postmarket surveillance of drugs, biologics, and medical devices.
Opportunity Snapshot
- Agency: U.S. Food and Drug Administration (FDA)
- Estimated Value: $310M
- Expected RFP Release: October 2025
- Contract Purpose: Support the Sentinel 3.0 System, which consolidates postmarket safety surveillance across FDA’s CDER, CBER, and CDRH.
- Key Components:
- Sentinel Coordinating Center (SCC): Managed across FDA centers and the Office of the Commissioner.
- Program Management Organization (PMO): Established in September 2024 to provide program/project management and collaboration platform support.
- Data Hub: Access to diverse healthcare data (claims, EHR, registries, HIE, vaccine and device utilization data).
- Data Platform: AI-enabled repository, standardized terminologies, FedRAMP cloud environment.
- Scientific Support Services: Advanced pharmacoepidemiology, pharmacovigilance, and AI-based analytics.
- NAICS: TBD (likely 541715 – R&D in the Physical, Engineering, and Life Sciences, or 541990 – All Other Professional, Scientific, and Technical Services).
Why This Matters
The Sentinel 3.0 Initiative is the FDA’s central framework for active postmarket risk identification and analysis, fulfilling legislative requirements under the FDA Amendments Act of 2007. By linking diverse health data sources covering more than 100 million patients, the system enables the FDA to rapidly detect, assess, and respond to public health and product safety issues—including in times of emergency.
This contract offers opportunities for businesses with expertise in:
- Healthcare data integration and informatics
- AI/ML-enabled analytics
- FedRAMP-authorized cloud environments
- Large-scale program management
- Pharmacoepidemiology and pharmacovigilance
How OST Can Help You Win
The Sentinel 3.0 contract will demand complex, multi-disciplinary expertise—from health IT and AI-driven analytics to regulatory knowledge and strategic teaming. Few firms can meet those demands alone. That’s where OST comes in.
We don’t just write proposals—we help you win contracts that transform your pipeline. Our team can:
- De-risk your pursuit. We identify capture gaps early, map solutions to the FDA’s technical and compliance requirements, and strengthen your win themes with measurable proof points.
- Assemble winning teams. We connect you with partners in our network of more than 200 partners who bring specialized healthcare data, AI/ML, epidemiology, and informatics capabilities—so you present a complete, competitive solution to the FDA.
- Boost capacity under pressure. Whether you need surge support during crunch time or full proposal management from day one, we add horsepower exactly where it’s needed to deliver compliant, compelling proposals.
- Accelerate your growth. We’ve supported clients in winning more than $22 billion in federal contracts, giving us a proven track record of helping businesses move from opportunity pursuit to award.
If Sentinel 3.0 is on your radar, now is the time to act. OST ensures you don’t just submit a proposal—you submit a winning proposal.
Don’t Miss Out
FDA’s Sentinel 3.0 RFP is expected in October 2025. Start preparing your capture strategy now to position your business for success.
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