Clinical Trial Management System
End-to-end study lifecycle management, from protocol design to database lock, in a single integrated environment.
Built for Modern Trial Complexity
Every feature designed around the workflows clinical operations teams actually use.
Study Setup & Configuration
Template driven protocol configuration with multi-arm, multi site, and adaptive design support. Define visit schedules, randomization schemes, and stratification factors in a visual builder.
Site Management
Centralized site selection, qualification tracking, and performance dashboards. Monitor enrollment velocity, protocol deviations, and query resolution rates across all sites in real-time.
Enrollment Tracking
Real-time enrollment dashboards with AI powered predictions. Identify underperforming sites early, forecast completion dates, and trigger automated escalation workflows.
Milestone & Budget Tracking
Gantt based milestone planning with automated progress tracking. Link financial milestones to deliverables and generate real-time budget burn reports.
Document Management
TMF ready document repository with version control, eSignature workflows, and automated filing based on DIA TMF reference model categories.
Safety Reporting
Integrated SAE/SUSAR workflow with automated timeline tracking, MedDRA coding, and regulatory submission generation for CIOMS-I and MedWatch forms.
Regulatory Submissions
Built-in eCTD module tracking with submission planning, health authority correspondence management, and approval milestone automation.
How It Works
Three steps from protocol to production.
Design Your Study
Configure your protocol in the visual study builder. Define arms, visits, assessments, and randomization, then deploy across sites with a single click.
Activate & Monitor
Onboard sites, train investigators, and begin enrollment. Real-time dashboards and AI predictions keep your study on track with proactive risk management.
Analyze & Submit
Generate regulatory ready reports, export CDISC compliant datasets, and prepare submission packages, all from within the platform.
Ready to Modernize Your Clinical Trials?
Join leading sponsors, CROs, and research sites using Vitruvian Shield to run faster, smarter, and more compliant trials.
Or contact our team for a personalized walkthrough.