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Clinical Data Safety Analysis

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

This contract involves providing project management support for the BIRRS team's activities within the FDA's Office of New Drugs (OND), focusing on initiatives like the Standard Safety Tables and Figures, FDA Medical Queries, and Safety Analytics Office Hours. Contractors will assist in delivering resources to OND reviewers and promoting standardization across the office, including offering training on safety analytics tools. The work also covers supporting clinical informatics projects that utilize informatics and computer programming to analyze large clinical trial data sets and enhance tools such as the FMQ Browser, which aids in safety signal detection for marketing applications. Funds will be used to maintain and improve existing FDA Medical Queries and dashboards for better user experience while developing new algorithmic and standard FMQs. The contract emphasizes leveraging AI, machine learning, and data analytics to explore trial data, particularly in areas like assessing variables related to drug effects on the liver to support regulatory guidance. The scope includes generative AI pilot projects utilizing large language models to answer questions about FDA Guidance documents, as well as other safety analytic initiatives such as developing classifiers for adverse event assessment and predictive tools related to medication safety. This effort supports enhancing informatic tools and solutions to improve clinical safety data analysis within the FDA.

General Info

Project management and data analytics support for FDA drug safety, AI tools development, and training.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedMay 25

forecast

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / Agency

Food and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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