PROJECT

TB-CTMS: A Customized Clinical Trial Management System for Integration and Digitization of Tuberculosis Clinical Trial Data

August 2026 - March 2027

Objectives:

To develop a comprehensive Clinical Trials Management System (CTMS) for ICMR–NIRT, designed to support and streamline operations across the clinical research lifecycle for Tuberculosis

Study Overview:

The Clinical Trial Management Systems (CTMS) facilitate the integration of different sources of data and their variety, such as images and structured data to manage longitudinal data, ensure data standardization, and facilitate the digitization of retrospective data—all of which are specific to TB investigations. Also, this System is to digitize the CRF forms and transform the way clinical trials are managed. It will yield operational efficiency, data integrity with connected workflows, and data visibility while reducing significant manual effort

Study Approach:

Automated Workflow: Automated workflows across various clinical forms eliminate the need for manual data entry (selected laboratory results, X-ray images), reduce human error, and significantly enhance data integrity and completeness. Centralized Data Management: Seamless integration with existing platforms through robust Application Programming Interface (API) connections, enabling real-time data exchange and standardization across the entire clinical research ecosystem

Expected Public Health Impact:

Reduced data entry errors and automated analysis could shorten trial timelines, accelerating research outcomes and the time to present the analysis. Improved data quality through digitized and standardized CRFs ensures complete alignment and connectivity. CTMS enhances data sharing and cross-trial comparability. Streamlined operations and a centralized platform eliminate fragmented processes, reducing administrative burdens and allowing research staff to focus on core scientific activities.