rSDV (Remote Source Data Verification)

Transform CRA Monitoring with Digital Oversight

Digital Transformation of Clinical Monitoring

rSDV revolutionizes clinical research monitoring by enabling remote source data verification through secure digital workflows, comprehensive audit trails, and role-based collaboration tools.

Core Modules

Visit-based Folder Structure

Study → Site → Visit → Subject → Folder for organized document management.

Role-Based Access

CRC uploads; CRA reviews with appropriate permissions and workflows.

PDF Upload with Editing & Redaction

Complete document management system with advanced editing capabilities.

Annotation

Highlighting, Comments, Tags for comprehensive document review.

Audit Trail

For every action with complete tracking and compliance logging.

21 CFR Part 11 Compliance

Full regulatory compliance assured for pharmaceutical research.

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

Backend Architecture

ASP.NET Core MVC v6

Modular, secure application architecture with modern development practices

RESTful API Support

Third-party integrations with comprehensive API endpoints

Hybrid Database System

MySQL for structured data, MongoDB for flexible hierarchical data

Frontend Technology

Modern Web Stack

Bootstrap 5 + jQuery + AJAX + DataTables for responsive interfaces

PDF.js Express

In-browser annotation and redaction capabilities

Role-Specific Views

Customized navigation, workflows, and dashboards per user role

Compliance & Quality

US FDA 21 CFR Part 11 Compliance

Full regulatory compliance for pharmaceutical clinical trials

Encrypted Data Transfer

SSL/TLS encryption ensures secure data transmission

Time-stamped Audit Trails

Complete tracking of all system activities for compliance

eSignatures

Multi-role signing capabilities for document approval workflows

System Validation

Full system validation and SOP-based deployment processes

Benefits for Sponsors & CROs

Faster Study Start-up

with intuitive setup

Real-time Monitoring

of study progress and quality

Improved Data Quality

through validations and audit trails

Cost Savings

with optimized operations and fewer queries

Regulatory Compliance

with global standards