Clinical Data Safety Analysis
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $700,000 to $1,500,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is seeking contractor support for project management and clinical data safety analysis initiatives under its BIRRS (Biomarkers, Imaging, and Related Sciences) program. The work encompasses maintaining and enhancing FDA Medical Queries (FMQs) and related dashboards, developing standard safety tables and figures, providing training for safety analytics tools, and leveraging artificial intelligence and machine learning capabilities to explore clinical trial data. Key objectives include improving user experience for FDA reviewers, creating additional algorithmic FMQs, assessing drug effects on liver functions, and developing innovative tools such as generative AI applications for analyzing FDA guidance documents and adverse event classifiers. The solicitation is estimated to release on November 1, 2025, with an anticipated award date of April 1, 2026.
The estimated contract award value ranges from $700,000 to $1,500,000 under NAICS code 541690 (Other Scientific and Technical Consulting Services). This is a new requirement with no set-aside restrictions, indicating open competition among qualified contractors. Interested parties should direct inquiries to the Food and Drug Administration's Acquisition Liaison at cderacquisitions@fda.hhs.gov. The work will support the FDA's Office of New Drugs (OND) and benefit clinical reviewers across the organization through standardized safety analytics resources and enhanced informatics solutions.
Forecast text
This work is project managment support for BIRRS activities such as the Standard Safety Tables and Figures, FDA Medical Queries, and OND Safety Analytics Office Hours. The project managment support provided by contractors will enable the delivery of multiple resources to reviewers across OND and promote standarization across the office. This request includes additional support, including training for safety analytics tools.
The BIRRS team develops clinical informatics projects in support of OND clinical reviewers such as the FDA Medical Queries (FMQs) project which is designed to promote safety signal detection clinical trial data analyses for marketing applications. These projects frequently require computer programing and informatics expertise to identify best solutions or test potential options using large clinical trial data sets. This use case will provide this type of support, as well as the computer programming expertise needed to maintain and enhance existing tools such as the FMQ Browser. Requested funds will be used to maintain and improve exisiting FMQs and the dashbord for enhanced user experience, develop additional algorithmic and standard FMQs.Leverage AI/ML/data analytics to explore trial data in support of the development of informatic tools and solutions. Such work will include assessing variables related to drug effects on liver to support regulatory guidance work, and the generative AI pilot project that is investigating the ability of large language models to answer questions regarding the contents of FDA Guidance documents. Additional AI work may include other safety analytic related initiatives such as the development of classifiers trained on safety reports and used to assess the likelihood of an adverse event being caused by a medication based on the information provided in a case narrative, or tools that predict the likelihood of a medication
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