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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

The contract provides project management support for BIRRS activities within the Food and Drug Administration’s Office of New Drugs, focusing on clinical data safety analysis initiatives such as the Standard Safety Tables and Figures, FDA Medical Queries, and OND Safety Analytics Office Hours. The goal is to enhance the delivery of analytical resources to reviewers across the office and promote consistent methodologies through standardized tools and processes. This includes maintaining and improving existing platforms like the FMQ Browser and associated dashboards to improve usability, developing new algorithmic and standardized medical queries, and expanding the use of clinical trial data for safety signal detection in marketing applications. Additional support involves training personnel on safety analytics tools to build internal capacity and ensure effective adoption of new technologies. The work also incorporates advanced data science capabilities including artificial intelligence, machine learning, and generative AI to address complex regulatory challenges. Specific efforts include leveraging large language models to answer questions about FDA guidance documents, developing classifiers that assess the likelihood of adverse events being drug-related based on case narratives, and building predictive tools to evaluate medication risks. Projects will further explore variables tied to drug effects on liver function to inform regulatory guidance, aligning analytic outputs with evolving safety standards. All activities require strong programming and informatics expertise to handle large-scale clinical datasets and translate findings into actionable, scalable tools that support regulatory decision-making across the agency.

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