Japan TCS Launches AI-Powered Solutions for Pharmaceutical Development and Safety Operations

July 1, 2026 | Tata Consultancy Services Japan Ltd. (Headquarters: Minato-ku, Tokyo; President: Satish Thiagarajan; hereinafter referred to as Japan TCS) announced today the launch of two AI solutions that leverage generative AI to support medical writing and literature screening operations.

In recent years, the pharmaceutical industry has seen a significant increase in the workload of safety management operations due to the growing volume of literature and related data, as well as the increasing sophistication of regulatory requirements in various countries. This has led to a need to create high-quality documents within limited timeframes while ensuring expertise, accuracy, consistency, and traceability, thereby increasing operational complexity.

Meanwhile, in the pharmacovigilance (PV) domain, similar to pharmaceutical development, there is a high dependence on specialized personnel, and the shortage of such talent is becoming severe. Traditional, person-dependent operational structures are unable to avoid variations in quality and uneven distribution of workload, facing structural challenges that cannot withstand business expansion or increased load.

Particularly in the Japanese market, it is difficult to apply the same systems used overseas directly to Japanese services due to the need to comply with Japan's unique regulatory requirements and provide Japanese language support. This poses a challenge to the advancement of automation and efficiency in the domestic PV domain.

In response to these challenges, Japan TCS has combined its specialized knowledge accumulated over many years in medical writing, ICSR operations, and literature screening with the latest AI technology to develop and launch practical solutions that are GxP (Good x Practice) compliant. These solutions enable AI-based support for 1. primary draft creation in medical writing operations and 2. literature screening, supporting both Japanese and English languages.

1. AI Tool for Supporting Draft Creation in Medical Writing Operations

This tool utilizes generative AI to support the creation of various reports in pharmaceutical development and PV domains. It targets the creation of initial drafts for pharmaceutical and medical device companies, assisting in the preparation of documents such as summaries for re-examination applications, periodic safety update reports, annual clinical trial reports, DSUR (Development Safety Update Report), and PBRER (Periodic Benefit-Risk Evaluation Report).

Based on source documents such as ICH guidelines, CSR (Clinical Study Report), protocols, templates, and safety information lists output from Safety DB (Database), the tool extracts necessary information and generates drafts in accordance with regulatory requirements and guidelines, contributing to the efficiency of writing and review processes and shortening lead times.

Solution Overview:

AI Medical Writing Service

Combines AI and specialized expertise to provide automated generation of initial drafts for various regulatory documents, along with QC (Quality Control) and revisions, as a BPaaS (Business Process as a Service). It offers total support, including operational planning and workflow proposals, not just system provision, to improve operational efficiency and quality.

Support for Diverse Document Types

Supports multiple document types, including safety reports, interim and final reports from post-marketing surveillance, and initial drafts of medical papers.

Human-in-the-Loop Design

Ensures quality through collaboration between AI and humans, assuming prompt design and confirmation/editing by domain specialists.

Integrated Optimization of the Writing Process

Supports the efficiency of the entire process, from writing and QC to proofreading and review.

Document Output Function

Generated drafts can be output in Word format.

Operational Efficiency and Quality Standardization

Reduces QC time and standardizes it through a section reference consistency check function.

Contributes to reducing writing and review workload and minimizing quality variations.

This tool is planned to be expanded to support the creation of a wider range of medical documents by extending its capabilities to cover more therapeutic areas and document types.

2. AI Tool for Literature Screening Support

This tool utilizes LLM and natural language processing technology to support medical literature screening operations. By analyzing PDF literature and automatically extracting and organizing adverse events, clinical events, drug usage information, and potential research reports, it enhances the operational efficiency and quality for PV personnel. This AI system is developed and provided to support the confirmation of large volumes of literature and the assessment of individual cases and determination of the need for research reports within short timeframes, which are challenges in safety management operations.

Solution Overview:

AI Literature Screening Service:

Combines AI and specialized expertise to provide literature screening operations as a BPaaS (Business Process as a Service). It offers total support, including operational support by a specialized PV team, not just system implementation.

Extraction of Adverse Events (AE) and Potentially Related Events:

Automatically analyzes PDF medical literature from domestic and international sources, extracting text from the body, including Japanese and English.

Event x Drug Association:

Associates extracted events with company drug information to support safety assessment operations.

Support for ICSR (Individual Case Safety Report) Determination:

AI assists in determining the possibility of an event being an ICSR.

Special Situation (SS) Detection:

Automatically detects events that may be Special Situations, such as off-label use or cases involving pregnancy.

Determination of Need for Research Reporting:

AI evaluates the applicability for research reporting and automatically extracts literature requiring confirmation.

Presentation of Supporting Sentences and Context:

Provides supporting sentences and surrounding context for AI extraction results, facilitating efficient review operations and quality improvement.

AI x Expert Review Hybrid Operation:

Achieves both quality improvement and high efficiency by combining comprehensive extraction by AI with review by specialized PV personnel.

Reduction of Workload and Personal Dependence:

Supports reduction of literature evaluation time, decreased secondary review workload, and standardization of judgment criteria, contributing to the efficiency and quality uniformity of PV operations.

This solution utilizes AI, natural language processing, and retrieval technology for contextual analysis to support evidence-based literature evaluation by analyzing medical literature, package inserts, guidelines, and safety information across different sources. In the future, it aims to achieve an industry-wide, standardized literature evaluation platform that is not dependent on individual company judgments, by further enhancing evaluation perspectives based on knowledge of guidelines and safety assessments.

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About Tata Consultancy Services Japan Ltd. (Japan TCS)

Japan TCS provides services and solutions across business, technology, and engineering domains, leveraging IT and digital technologies. Based on a deep understanding of Japanese business practices and the strengths of Japanese companies, Japan TCS has built its unique "Japan-centric Delivery Model (JDM)" to support the businesses of its Japanese clients with the solid knowledge and track record of Tata Consultancy Services (TCS). At its Japanese locations and the "Japan-centric Delivery Center (JDC)" in India, a total of 10,000 professional personnel collaborate seamlessly, tackling various business challenges with flexible scalability and abundant capabilities. With a vision to be a "Gateway to Globalization" and a "Catalyst for Technology-led Business Innovation," Japan TCS is dedicated to realizing its clients' purpose through business growth and transformation.

For more information about Japan TCS, please visit www.tcs.com/jp-ja/.