Adverse Drug Reaction Screening & Reporting from Literature Documents

Adverse Drug Reaction Screening & Reporting from Literature Documents is an advanced, Deloitte-built AI solution designed to transform pharmacovigilance by automating the end-to-end process of adverse event identification, extraction, validation, and regulatory reporting from scientific literature. This multi-agent framework empowers case processors and safety teams to efficiently manage the growing volume and complexity of drug safety data, determining compliance with global regulatory requirements.

Solution Overview

The system leverages a coordinated set of specialized agents—Orchestrator Agent, Literature Screening Agent, Adverse Event Extraction Agent, Report Generation Agent, and Knowledgebase Agent—to autonomously search, extract, validate, and report relevant safety information from a wide range of literature sources. By integrating with public databases such as PubMed, MedLine, and other scientific repositories, the solution provides coverage and up-to-date monitoring of potential adverse drug reactions (ADRs).

Key Features

Automated Literature Search: The Literature Screening Agent continuously scans scientific journals, regulatory bulletins, and clinical trial publications for new and relevant safety information based on user-defined queries or automated monitoring protocols.

Intelligent Data Extraction: The Adverse Event Extraction Agent uses advanced natural language processing (NLP) and machine learning techniques to accurately identify and extract adverse event data, including drug-event relationships, patient demographics, outcomes, and other critical details.

Validation & Knowledge Integration: The Knowledgebase Agent cross-references extracted data with existing safety databases and regulatory guidelines to validate findings, highlight novel signals, and reduce false positives.

Regulatory Report Generation: The Report Generation Agent automatically converts validated adverse event information into standardized regulatory submission formats, such as Individual Case Safety Reports (ICSR), determining readiness for global health authority requirements.

Orchestration & Workflow Management: The Orchestrator Agent coordinates the activities of all specialized agents, manages user inquiries, and facilitates workflow execution from literature search to report submission.

Inputs

User Inquiries: Enables users to retrieve specific adverse event information or initiate signal detection queries.

Public Databases: Integrates with scientific journals, publications, and research articles from sources like PubMed, MedLine, and other reputable repositories.

Outputs

Regulatory Reports: Generates adverse event information in regulatory-compliant formats (e.g., ICSR) for submission to health authorities.

Signal Detection: Identifies unexpected or high-frequency adverse events, providing early warnings and supporting proactive risk management.

Benefits

Efficiency & Scalability: Automates manual, time-consuming processes, enabling case processors to handle large volumes of literature with greater speed and accuracy.

Regulatory Compliance: Determines adherence to evolving global pharmacovigilance standards and reporting requirements.

Enhanced Signal Detection: Improves the ability to detect and respond to emerging safety signals, supporting better patient outcomes and risk mitigation.

Auditability & Traceability: Maintains a transparent, auditable record of actions and decisions, supporting internal reviews and regulatory inspections.

This professional service utilizes Amazon Bedrock, Bedrock Agents, Strands Agents, Lambda and OpenSearch.