Clinion CTMS (Clinical Trial Management System) is a comprehensive software solution designed to facilitate and streamline the management of clinical trials. It integrates various aspects of clinical trial operations, offering tools for planning, tracking, and reporting trial activities. By centralizing information, Clinion CTMS enhances efficiency, compliance, and collaboration among clinical trial stakeholders.
Key Features of Clinion CTMS
- Study Planning and Setup:
- Supports protocol development and trial setup workflows.
- Facilitates site selection and activation processes.
- Tracks key milestones and trial timelines.
- Site and Investigator Management:
- Maintains a centralized database of sites and investigators.
- Tracks investigator qualifications, certifications, and training.
- Monitors site performance and compliance.
- Budgeting and Financial Management:
- Automates budget creation and tracks financial activities.
- Manages payments to sites and investigators.
- Provides real-time tracking of trial expenditures.
- Regulatory and Document Management:
- Stores and organizes essential trial documents in compliance with ICH-GCP and 21 CFR Part 11.
- Offers tools for version control and audit trails.
- Simplifies submission processes for regulatory approval.
- Task and Issue Management:
- Tracks tasks and responsibilities across the study team.
- Logs and monitors issues, deviations, and corrective actions.
- Ensures timely resolution of trial challenges.
- Monitoring and Reporting:
- Facilitates site monitoring with visit scheduling and report templates.
- Provides real-time dashboards and customizable reports for trial progress.
- Tracks key performance indicators (KPIs) to measure trial efficiency.