CTMS / Clinical Trials
Clinical Trial Management System
Core Capability Features
- Online Monitoring reports
- Online QA scheduling
- File archive
- File repository for Trial Master File (TMF)
- SOP Management
- 21 CFR Part 11 Regulatory Compliance
- Responsive framework for Smart devices, Tablets & PCs
The Clinical Trial Management System (CTMS) centralizes critical clinical trial metadata and structures communications seamlessly among sponsors, clinical trial monitors, investigators, and operational stakeholders.
By acting as a single source of truth, it orchestrates tracking metrics from site assessment rules down to real-time milestone validations.
The CTMS platform can be deployed as an independent stand-alone ecosystem or integrated directly into our electronic data capture engine (EDC System Suite).
Platform Highlights & Deep-Dive Details
Online Monitoring & Quality Metrics
Online Monitoring Reports
Online QA Tracking Audits
Monitors can configure, author, and submit comprehensive operational reports for Site Qualification, Site Initiation, routine monitoring updates, and final closure visits directly inside the web portal. These parameters are dynamic and fully customizable to fit unique validation checklists.
Centralized QA Reports
Quality Assurance teams can securely manage oversight workflows by writing and signing off internal auditing actions directly within the central CTMS directory.
Trial Documentation Control
Global Asset Distribution Channel
Electronic Trial Master File (eTMF)
Our centralized secure file archive gives cross-functional teams a safe place to share critical protocol documents, updates, and templates with site investigators, institutional review boards, and external contractors instantly.
Electronic Trial Master File Framework
A separate, high-security directory provides your studies with a robust electronic Trial Master File (eTMF) archive layout. Granular user access controls ensure that viewing, uploading, and deleting permissions match your exact standard operating protocols.
Operational Standard Compliance
Active vs Obsolete Lifetime Rules
Digital Asset PDF Attachment Storage
The system's SOP engine is built from the ground up to catalog, sort, and deliver active standard operating procedures whenever audits require them. It gives everyone a unified reference point for training compliance across all active clinical sites.
By letting you attach digital signatures and original file copies, it removes standard documentation gaps and ensures that your teams always pull from current versions.
FDA & EMA Validated Systems
21 CFR Part 11 Compliant Structure
Immutable Exportable Audit Trail
Granular User Access Control Matrices
Like the rest of our clinical trial tools, the CTMS meets the strict requirements set by global health authorities for digital electronic record applications.
An automated, immutable system-wide audit trail logs every system action with accurate timestamps and user tags. Multi-level account settings make it simple to restrict system views, edit properties, and form submission access to authorized personnel only. Catching source data electronically minimizing transcription errors and boosts the overall integrity of your trial database.
Flexible Deployment Options
Secure Infrastructure Technology Transfer
Fully Managed Enterprise Cloud Hosting
We configure deployment settings to match your specific corporate IT or regulatory requirements: choose to deploy directly within your own private corporate servers, or rely on our fully managed cloud environment.
Instead of locking you into a rigid out-of-the-box system, we analyze your exact study goals to build a tailored, cost-effective workspace that fits perfectly with your team's real-world processes.