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
-
- Christopher Scott christopher.scott@fda.hhs.gov
- tbd@fda.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Department of Health and Human Services Food and Drug Administration (FDA) is seeking project management support for BIRRS (Biomedical Informatics and Regulatory Research Services) activities, focusing on clinical data safety analysis. The contract involves developing and maintaining clinical informatics projects, including Standard Safety Tables and Figures, FDA Medical Queries (FMQs), and safety analytics tools, with an emphasis on leveraging AI/ML technologies for data exploration and regulatory guidance. The estimated solicitation release date is February 1, 2026, with an anticipated contract award on April 1, 2026.
While specific award values are not disclosed, the contract will support the OND (Office of New Drugs) by providing computer programming expertise, developing algorithmic tools, and enhancing existing dashboards and browsers for safety signal detection. The work includes exploring AI applications such as developing classifiers for adverse event assessment and investigating generative AI capabilities for interpreting FDA guidance documents. Key points of contact are Christopher Scott (christopher.scott@fda.hhs.gov) and a TBD mailbox (tbd@fda.gov), both associated with the Food and Drug Administration, with the contract falling under the NAICS code 541690 for Other Scientific and Technical Consulting Services.
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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