rSDV (Remote Source Data Verification)

Transform CRA Monitoring with Digital Oversight — rSDV revolutionizes clinical research monitoring through secure digital workflows, comprehensive audit trails, and role-based collaboration tools.

60%
Faster Monitoring
Paperless
CRA Workflow
SDV/SDR
Remote Verification
21 CFR
Part 11 Ready

Core Modules

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Visit-based Folder Structure
Study → Site → Visit → Subject → Folder for organized document management.
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Role-Based Access
CRC uploads; CRA reviews with appropriate permissions and workflows.
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PDF Upload with Editing & Redaction
Complete document management with advanced editing capabilities.
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Annotation
Highlighting, Comments, Tags for comprehensive document review.
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Audit Trail
For every action with complete tracking and compliance logging.
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21 CFR Part 11 Compliance
Full regulatory compliance assured for pharmaceutical research.

Backend Architecture

ASP.NET Core MVC v6 + Hybrid Database (MySQL + MongoDB)

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ASP.NET Core MVC v6
Modular, secure application architecture with modern development practices.
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RESTful API Support
Third-party integrations with comprehensive API endpoints.
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Hybrid Database System
MySQL for structured data, MongoDB for flexible hierarchical data.

Frontend Technology

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Modern Web Stack
Bootstrap 5 + jQuery + AJAX + DataTables for responsive interfaces.
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PDF.js Express
In-browser annotation and redaction capabilities.
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Role-Specific Views
Customized navigation, workflows, and dashboards per user role.

Compliance & Quality

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US FDA 21 CFR Part 11 Compliance
Full regulatory compliance for pharmaceutical clinical trials.
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Encrypted Data Transfer
SSL/TLS encryption ensures secure data transmission.
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Time-stamped Audit Trails
Complete tracking of all system activities for compliance.
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eSignatures
Multi-role signing capabilities for document approval workflows.
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System Validation
Full system validation and SOP-based deployment processes.

Benefits for Sponsors & CROs

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Faster Study Start-up
with intuitive setup
visibility
Real-time Monitoring
of study progress and quality
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Improved Data Quality
through validations and audit trails
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Cost Savings
with optimized operations and fewer queries
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Regulatory Compliance
with global standards
rSDV Platform

Modernize your CRA monitoring process.

Replace paper-based SDV with secure, digital remote monitoring that accelerates closeout and ensures data integrity.

Request a Demo Learn More