Clinical Trial Management System for Sponsors and CROs
AIClinTrack CTMS helps sponsors, CROs and clinical operations teams manage study setup, sites, monitoring, milestones and clinical oversight — with compliance-ready controls and audit-ready activity history.
Unified clinical trial oversight, without stitched-together tools
Bring study setup, site management and monitoring oversight into a single CTMS designed for the way sponsors and CROs actually run trials. Every key action is retained as audit-ready activity history.
Study setup & lifecycle
Configure studies and manage them through their operational lifecycle, from planning to close-out activities.
Site management
Maintain sites, track site activation readiness and keep site-level status visible across the study.
User & study role assignments
Assign users to studies with role-based access so the right teams see the right information.
Regulatory approval tracking
Track country and site regulatory approvals to support activation decisions and oversight.
Monitoring oversight
Coordinate monitoring activity and surface risk signals for clinical operations teams.
Milestones & reports
Track study milestones and generate operational reports for sponsors and CRO stakeholders.
Audit-ready activity history
Retain a detailed record of key actions to support audit-ready workflows and oversight.
RBQM Center (within CTMS)
Risk-based quality management capabilities are provided within the CTMS to support risk-based monitoring oversight.
QMS (within CTMS)
Quality management workflows — controlled documents, CAPAs, deviations and audit tracking — are built into the CTMS.
A clear workflow from study setup to oversight
AIClinTrack CTMS supports the operational lifecycle of a clinical trial with structured, trackable steps.
- 1
Set up the study
Define the study, add sites and configure roles so teams can begin structured, tracked work.
- 2
Activate sites
Track regulatory approvals and site activation readiness to support informed activation decisions.
- 3
Oversee monitoring
Coordinate monitoring activity and review risk signals through the RBQM Center within CTMS.
- 4
Track milestones & report
Follow milestones and generate operational reports backed by audit-ready activity history.
Built for sponsors, CROs and clinical operations teams
Clinical trial management software should match the responsibilities of the people using it. AIClinTrack CTMS supports each of these roles.
Sponsors
Central oversight of studies, sites and milestones across a portfolio, with role-based visibility for operations leadership.
CROs
Coordinate study startup, site management and monitoring on behalf of sponsors with structured, auditable workflows.
Clinical operations teams
Day-to-day management of site activation readiness, monitoring visits and study milestones in one workspace.
Risk-based quality management and QMS, built into the CTMS
RBQM and QMS are part of AIClinTrack CTMS — not separate tools to license and integrate. Here is what they add on top of core study, site and monitoring management.
RBQM — Risk-Based Quality Management
The RBQM Center adds a risk lens across the study, so monitoring effort follows the risk instead of a flat, one-size-fits-all approach.
- Centralized risk assessment. Maintain a study-level risk register so operational, quality and safety risks are identified and tracked in one place.
- Key Risk Indicators (KRIs). Monitor KRIs with thresholds so emerging risk signals at the site and study level surface early.
- Quality Tolerance Limits (QTLs). Define QTLs for critical-to-quality factors and watch for breaches that may need action.
- Risk-based monitoring & escalation. Prioritize monitoring effort using site risk scoring and escalate issues to the right owners.
QMS — Quality Management System
The QMS adds structured quality workflows — controlled documents, CAPAs, deviations and audit readiness — connected to the same audit-ready activity history.
- Controlled document & SOP management. Manage SOPs and controlled documents with versioning so teams always work from the current, approved version.
- CAPA & deviation management. Log deviations and manage corrective and preventive actions (CAPA) through to resolution with an auditable trail.
- Audit & inspection readiness. Plan audits, track findings and keep evidence organized to support inspection-ready quality operations.
- Training & quality events. Track training records and quality events so responsibilities and follow-ups stay visible across the study.
Controls that support audit-ready clinical operations
AIClinTrack CTMS uses 21 CFR Part 11 readiness-aligned and audit-ready workflows, role-based governance and detailed activity history. These controls are designed to support your compliance processes — they are not a substitute for your own validation and inspection preparation.
- Role-based access aligned to study responsibilities.
- Audit-ready activity history for key actions across the study.
- Compliance-ready controls that support your validation-ready evidence package.
Frequently asked questions about our CTMS
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See AIClinTrack CTMS in action
Request a demo to see how sponsors and CROs manage study setup, sites and monitoring oversight in one platform.