Clinical Trial Management System (CTMS)

A comprehensive, fully validated platform for managing every aspect of clinical trial operations. From site identification and feasibility through study close-out, our CTMS delivers real-time operational visibility, financial oversight, and milestone compliance across your entire clinical programme.

21 CFR Part 11 GDPR Compliant GAMP 5 Validated
CTMS Platform Overview

Comprehensive Trial Operations Management

Our Clinical Trial Management System is the operational backbone of your clinical programme, providing a single, unified platform for managing sites, milestones, budgets, resources, and documents. Purpose-built for the complexities of multi-site, multi-country clinical trials, the CTMS integrates seamlessly with our broader eClinical ecosystem to eliminate data silos and deliver a complete operational picture.

Whether you are a sponsor managing a global portfolio, a CRO balancing multiple client programmes, or a site team coordinating daily activities, our CTMS adapts to your workflows and delivers the visibility you need to make faster, smarter decisions.

Multi-Country
Multi-Study
Real-Time

End-to-End Trial Operations

Six integrated modules covering every operational dimension of clinical trial management, from site activation through study close-out and financial reconciliation.

Site Management

Full site lifecycle management from initial feasibility assessment and site selection through activation, ongoing monitoring, and close-out activities.

  • Site feasibility and selection scoring
  • Site activation and initiation tracking
  • Monitoring visit scheduling and reporting
  • Site performance benchmarking
  • Close-out visit management

Milestone Tracking

Configurable milestone frameworks with automated progress monitoring, critical path analysis, and predictive timeline forecasting to keep your programme on track.

  • Configurable milestone frameworks
  • Critical path analysis and alerts
  • Timeline forecasting and simulation
  • Automated progress notifications
  • Cross-study milestone comparison

Financial Management

Comprehensive budget tracking, investigator payment management, change order processing, and financial forecasting dashboards to maintain fiscal oversight.

  • Budget creation and tracking
  • Investigator payment processing
  • Change order management
  • Financial forecasting dashboards
  • Accrual and variance reporting

Resource Planning

Strategic team allocation, capacity planning, and workload distribution tools that ensure the right resources are deployed across your clinical programme.

  • Team allocation and assignment
  • Capacity planning and forecasting
  • Workload distribution analysis
  • Resource utilisation reporting
  • Cross-study resource visibility

Operational Dashboards

Real-time KPI dashboards providing instant visibility into enrolment progress, site performance scorecards, and executive-level programme reporting.

  • Real-time KPI monitoring
  • Enrolment tracking and forecasting
  • Site performance scorecards
  • Country and region analytics
  • Executive summary reporting

Document & Contract Management

Centralised regulatory document tracking, contract lifecycle management, essential document collection, and automated compliance monitoring.

  • Regulatory document tracking
  • Contract lifecycle management
  • Essential document collection
  • Compliance monitoring and alerts
  • Automated expiry notifications

Tailored for Every Stakeholder

Our CTMS delivers role-specific views and functionality, ensuring each stakeholder sees exactly what they need to drive their part of the clinical programme forward.

Sponsors

Portfolio-level visibility and strategic oversight across all programmes and studies.

  • Portfolio-level programme visibility
  • Financial oversight and budget tracking
  • Milestone compliance monitoring
  • Cross-study performance analytics
  • Executive reporting dashboards

CROs

Multi-sponsor management tools with resource optimisation and standardised processes.

  • Multi-sponsor programme management
  • Resource optimisation and allocation
  • Standardised operational processes
  • Client-specific reporting views
  • Operational efficiency metrics

Site Teams

Clear task management, payment transparency, and streamlined document submission tools.

  • Clear task and visit management
  • Payment transparency and tracking
  • Document submission portal
  • Enrolment progress tracking
  • Communication and notification tools
CTMS Integration Ecosystem

Seamless Ecosystem Integration

Our CTMS does not operate in isolation. It connects with every module in the MTK eClinical platform through a shared data layer, delivering a unified operational view that eliminates double data entry and ensures consistency across all systems.

EDC Integration

Bi-directional data flow with EDC for automated enrolment tracking, query status monitoring, and data completeness metrics.

RTSM Integration

Real-time randomisation data feeds for enrolment dashboards, drug supply visibility, and treatment allocation tracking.

DocuVault Integration

Automated essential document status tracking, TMF completeness indicators, and regulatory compliance dashboards.

eConsent Integration

Consent status visibility per patient and site, re-consent tracking, and ICF version compliance monitoring.

Analytics Integration

Unified operational analytics combining CTMS data with EDC, RTSM, and ePRO metrics for holistic programme intelligence.

Why Choose Our CTMS

Built by clinical operations professionals who understand the daily realities of managing complex, global clinical trials across diverse therapeutic areas.

Unified Platform

Single sign-on, shared data layer, and seamless integration with all eClinical modules eliminates data silos and manual reconciliation.

Configurable Workflows

Adapt the platform to your operational processes with configurable workflows, role-based views, and custom field definitions.

Validated & Compliant

GAMP 5 validated, 21 CFR Part 11 compliant, and GDPR-ready with comprehensive audit trail and electronic signature support.

Rapid Deployment

Configurable, not custom-coded. Study setup in weeks with re-usable templates, standards libraries, and automated provisioning.

40%
Faster Site Activation
100%
Audit Trail Coverage
60%
Reduction in Manual Tasks
24/7
Real-Time Visibility

See CTMS in Action

Schedule a personalised demonstration to discover how our Clinical Trial Management System can streamline your trial operations, improve financial oversight, and deliver real-time visibility across your entire clinical programme.

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