Electronic Data Capture (EDC)
A powerful, fully validated EDC platform purpose-built for modern clinical trials. Capture, clean, and manage clinical data with confidence across multi-site, multi-country studies -- from first patient in through database lock and regulatory submission.
Purpose-Built for Clinical Trials
MTK's Electronic Data Capture platform is the foundation of our integrated eClinical suite. Designed by clinical data management professionals for clinical data management professionals, it combines intuitive eCRF design, real-time data validation, and risk-based monitoring capabilities within a single, validated environment.
Whether you are running a single-centre Phase I study or a global Phase III programme across hundreds of sites, our EDC adapts to your protocol complexity. With configurable workflows, reusable standards libraries, and seamless integration with our RTSM, ePRO, CTMS, DocuVault, and eConsent modules, you gain a unified data layer that eliminates silos and accelerates your path to clean, submission-ready data.
Everything You Need in One Platform
Our EDC delivers a comprehensive feature set designed to accelerate study setup, improve data quality, and provide real-time operational visibility from first patient enrolled through database lock.
Intelligent Form Builder
Design complex eCRFs with ease using our intuitive drag-and-drop form builder. Build sophisticated data collection instruments without writing a single line of code.
- Drag-and-drop eCRF design
- Conditional logic & skip patterns
- Dynamic calculations & derivations
- Real-time validation rules
Rapid Study Setup
Get your study live in weeks, not months. Our configurable platform leverages reusable templates and standards libraries to dramatically reduce study build timelines.
- Study setup in weeks
- Reusable form & visit templates
- CDASH standards library
- Automated UAT test scripts
Real-Time Data Validation
Catch data discrepancies at the point of entry and throughout the study lifecycle with automated edit checks, intelligent query generation, and resolution workflows.
- Automated edit check firing
- Intelligent query generation
- Site resolution workflows
- Query aging dashboards
Risk-Based Monitoring
Enable centralised monitoring with real-time dashboards that surface data quality signals, key risk indicators, and site-level risk scores for targeted, efficient oversight.
- Central monitoring dashboards
- KRI tracking & alerting
- Site risk scoring algorithms
- Data quality trend analysis
Complete Audit Trail
Maintain full regulatory compliance with a comprehensive, computer-generated audit trail that records every change, every signature, and every action across the system.
- 21 CFR Part 11 compliant
- Electronic signatures with reason codes
- Timestamped change tracking
- Tamper-evident record integrity
Multi-Language & Responsive
Run global trials seamlessly with site-level language selection, multi-script character support, and a device-agnostic interface for data entry at the point of care.
- Global trial language support
- Multi-script character sets
- Desktop, tablet & mobile access
- Point-of-care data entry
Built for Every Stakeholder
Our EDC platform is designed to meet the distinct needs of every clinical trial stakeholder, delivering tailored workflows and dashboards that make every role more efficient.
Sponsors
Gain complete visibility into your clinical programme with real-time oversight and data quality metrics across all sites and studies.
- Real-time data oversight dashboards
- Centralised monitoring capabilities
- Cross-study data quality visibility
- Regulatory submission readiness
CROs
Scale across multiple sponsors and studies with standardised processes, rapid database builds, and a platform built for multi-study management.
- Standardised multi-study management
- Scalable platform deployments
- Rapid database build & configuration
- Sponsor-level access partitioning
Site Teams
Enter data quickly and accurately with an intuitive interface designed to minimise training time, reduce query burden, and support point-of-care workflows.
- Intuitive, easy-to-learn interface
- Reduced query burden & faster resolution
- Point-of-care mobile access
- Offline data capture capability
One Platform. Zero Silos.
Our EDC is not a standalone tool -- it is the data backbone of MTK's integrated eClinical platform. Bi-directional data flows, single sign-on, and a shared data layer connect EDC with every module in the suite, eliminating manual reconciliation and ensuring a single source of truth for your clinical trial data.
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RTSM Integration
Automated eligibility verification, visit-driven drug dispensing, and real-time randomisation data flow between EDC and RTSM.
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ePRO / eCOA Integration
Patient-reported outcomes and clinician assessments flow directly into the EDC database with automated reconciliation and compliance tracking.
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CTMS Integration
Shared site and study metadata, visit schedule synchronisation, and real-time enrolment and milestone tracking across both systems.
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DocuVault eTMF Integration
Automated filing of signed CRF pages, data management plans, and edit check specifications directly to the Trial Master File.
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eConsent Integration
Consent status verification at data entry, automated consent version tracking, and re-consent workflow triggers linked to EDC events.
Why Choose MTK for EDC
Choosing the right EDC partner means more than selecting software. It means partnering with a team that understands clinical trials, regulatory expectations, and the operational realities of running studies across the globe.
Domain Expertise
Built and supported by professionals with deep clinical trial knowledge spanning data management, biostatistics, and regulatory affairs across all therapeutic areas.
Unified Platform
EDC is part of an integrated eClinical suite with RTSM, ePRO, CTMS, DocuVault, eConsent, rSDV, Analytics, and Adjudication -- all sharing one data layer.
Regulatory Ready
GAMP 5 validated, 21 CFR Part 11 compliant, and GDPR-ready out of the box. Complete validation documentation available for sponsor and regulatory review.
24/7 Support
Dedicated support team available around the clock for active studies. From helpdesk queries to system administration, our team is there when you need them.
See EDC in Action
Schedule a personalised demonstration to discover how MTK's EDC platform can streamline your clinical data capture, improve data quality, and accelerate your path from first patient in to database lock and regulatory submission.