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InChronicles

GxP software for document management, quality systems, and clinical trial automation in pharma and medical device R&D.

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Overview

Chronicles CTMS develops GxP-compliant software for pharmaceutical and medical device industries, covering the automation of document management, quality systems, and clinical and preclinical research. The platform is designed as a full-cycle solution for Research and Development teams, supporting the complete lifecycle of clinical trials and regulated documentation processes.

The company serves organisations operating in regulated industries, including pharmaceutical companies and medical device manufacturers, providing tools that address both quality management and clinical trial execution needs.

Core Products and Modules

  • CTMS (Clinical Trial Management System): A project management solution for overseeing clinical and preclinical trials, including logistics coordination and trial documentation.
  • eCRF / EDC (Electronic Case Report Forms / Electronic Data Capture): A system for data collection in clinical trials of drugs and medical devices, described as a robust and flexible tool for capturing trial data electronically.
  • eTMF (Electronic Trial Master File): A module for managing trial master file documentation in an electronic format.
  • eDMS (Electronic Document Management System): A solution for full-cycle automation of documentation management in regulated industries.
  • Quality Management: Functionality combined with eDMS to support quality systems automation in GxP environments.

Platform Capabilities

  • Full-cycle automation of documentation and quality management processes in regulated industries.
  • Support for clinical and preclinical trial project management, including logistics.
  • Electronic data capture designed for both drug and medical device trials.
  • GxP-compliant architecture suitable for pharmaceutical and medical industry requirements.
  • Flexible EDC configuration, as highlighted through customer experience cases such as the TUNECT deployment.

Recent Developments

  • Release of CTMS Version 2.0, announced in July 2025.
  • Published content covering topics such as the use of electronic systems in clinical trials and the role of flexible EDC in operational efficiency.
  • Ongoing news and events activity, including coverage of industry topics such as CT imaging technology (StereotaX8).

Chronicles CTMS positions its platform as an integrated suite covering the key electronic systems required for regulated R&D operations, from data capture and trial management through to document control and quality assurance.