rSDV (Remote Source Data Verification)

Transform CRA Monitoring with Digital Oversight

🔍Revolutionary Remote Monitoring

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

⚙️Technical Architecture

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

💡Complete Clinical Trial Solution

Unified Clinical Trial Operations Platform

💡 A comprehensive solution stack combining the power of Source Transcript (EDC), IWRS, and rSDV for complete clinical trial management.

Source Transcript (EDC)

Electronic Data Capture for clean, validated clinical data collection

IWRS

Interactive Web Response System for randomization and supply management

rSDV

Remote Source Data Verification for comprehensive CRA monitoring

⚙️ Ready for Phase I-IV trials | 100% configurable | Scalable | Audit-ready

All built on ASP.NET Core MVC v6 with MySQL + MongoDB hybrid database and hosted on a secure, scalable HostGator server.