Remote Source Data Verification (rSDV)
Enable secure, remote monitoring of clinical trial source data without the need for on-site visits. Our rSDV platform empowers CRAs to verify source documents remotely, strengthening oversight, reducing monitoring costs, and accelerating query resolution across your entire clinical programme.
Transforming Clinical Monitoring
MTK's Remote Source Data Verification platform redefines how sponsors, CROs, and site teams approach clinical trial monitoring. By providing secure, role-based remote access to source documents, rSDV eliminates the dependency on costly and time-consuming on-site monitoring visits while maintaining the highest standards of data integrity and patient privacy.
Whether you are managing a small Phase I study or overseeing a global Phase III programme, our rSDV platform integrates seamlessly with MTK's EDC, CTMS, DocuVault, and Analytics modules to deliver a unified monitoring ecosystem. Strengthen oversight, reduce travel expenditure, and accelerate query resolution -- all from a single, validated platform.
Comprehensive Remote Monitoring Tools
Our rSDV platform delivers a complete feature set designed to enable efficient remote source data verification, maintain patient privacy, and provide real-time visibility into monitoring progress across all sites and studies.
Remote Source Access
Secure, role-based remote access to source documents enabling CRAs to perform source data verification without the need for on-site visits. Granular permissions ensure that each user sees only the data they are authorised to review, with full audit trail logging of every access event.
Verification Workflows
Structured SDV workflows with configurable verification plans, customisable checklists, and completion tracking per visit and form. Define SDV targets at the study, site, or patient level, and monitor progress in real time against your monitoring plan.
Secure Document Upload
Encrypted document upload with built-in redaction tools, automatic watermarking, and comprehensive access logging. Designed to protect patient privacy at every step, ensuring that sensitive information is safeguarded throughout the verification process.
EDC Integration
Seamless bi-directional linking between EDC data fields and corresponding source documents. CRAs can navigate directly from an EDC field to the relevant source record, dramatically reducing verification time and improving accuracy.
Monitoring Dashboards
Real-time SDV progress tracking with site-level completion metrics, risk-based monitoring indicators, and configurable KRI thresholds. Identify sites requiring attention and allocate monitoring resources where they are needed most.
Cost Reduction Analytics
Comprehensive travel cost savings tracking, monitoring time reduction metrics, and oversight frequency analytics. Demonstrate the tangible ROI of remote monitoring with detailed cost comparison reports and efficiency dashboards.
Built for Every Stakeholder
Our rSDV platform is designed to meet the distinct needs of every clinical trial stakeholder, delivering tailored workflows and dashboards that enhance efficiency, reduce burden, and strengthen oversight across the monitoring lifecycle.
Sponsors
Gain enhanced oversight of your clinical programme without adding burden to investigator sites. Monitor verification progress in real time and adopt a risk-based approach to site monitoring.
- Enhanced oversight without site burden
- Real-time verification status visibility
- Risk-based monitoring approach
- Comprehensive compliance reporting
CROs
Significantly reduce monitoring travel costs while increasing CRA productivity and expanding oversight capacity. Manage verification workflows centrally across all sites and studies.
- Reduced monitoring travel costs
- Increased CRA productivity
- Centralised verification management
- Scalable across multiple programmes
Site Teams
Experience minimal disruption to daily clinical workflows with guided document upload processes and a significant reduction in the burden of on-site monitoring visits.
- Minimal disruption to site workflows
- Guided document upload process
- Reduced on-site visit burden
- Simple, intuitive site interface
Connected Across Your eClinical Suite
Our rSDV platform is not a standalone tool -- it is deeply integrated within MTK's unified eClinical ecosystem. Bi-directional data flows, single sign-on, and a shared data layer connect rSDV with every module in the suite, enabling CRAs to move seamlessly between source documents, EDC data, trial management records, and analytics dashboards.
-
EDC Integration
Direct bi-directional linking between EDC data fields and source documents. Navigate from any CRF field to the corresponding source record for instant verification.
-
CTMS Integration
Synchronised monitoring visit schedules, site metadata, and milestone tracking. rSDV activity feeds directly into CTMS monitoring reports and site performance dashboards.
-
DocuVault eTMF Integration
Automated filing of verified source documents and monitoring visit reports directly into the Trial Master File with full version control and audit trail.
-
Analytics Integration
rSDV metrics feed into the eClinical Analytics platform for cross-module risk scoring, monitoring efficiency dashboards, and executive programme reporting.
Why Choose MTK for rSDV
Choosing the right rSDV partner means more than selecting software. It means partnering with a team that understands clinical monitoring, regulatory expectations, and the operational realities of running remote verification across global programmes.
Domain Expertise
Built and supported by professionals with deep clinical monitoring knowledge spanning source data verification, risk-based monitoring, and regulatory compliance across all therapeutic areas.
Unified Platform
rSDV is part of an integrated eClinical suite with seamless EDC-to-source linking, CTMS synchronisation, DocuVault eTMF filing, and cross-module analytics -- all sharing one data layer.
Regulatory Ready
Fully aligned with ICH-GCP E6(R2) guidelines for remote monitoring, 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 and site onboarding, our team is there when you need them.
See rSDV in Action
Schedule a personalised demonstration to discover how MTK's rSDV platform can transform your clinical monitoring strategy, reduce travel costs, strengthen data oversight, and accelerate your path to clean, submission-ready data.