eCDMS – E-Clinical Data Management System | Soinsys
Product

eCDMS

E-Clinical Data Management System

An intranet and internet-based platform to manage the complete volunteer record lifecycle — from enrollment to MSR export, compliant with all operational & functional requirements.

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Active 247 ID: V-00421 SOP
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About eCDMS

Complete Clinical Data
Management

eCDMS is an intranet and internet-based software accessible by authorized users only, providing:

  • Electronic data set-up, update & historical records for every volunteer
  • Comprehensive Volunteer Record Management — SOPs, regulations & guidelines
  • Centralized control of rights via Role-Based Access based on profiles
  • End-to-end traceability from Enrollment to MSR Export
  • Fully compliant with all Operational & Functional Requirements
System Overview

What eCDMS Manages

eCDMS is a comprehensive suite of applications to manage the entire Volunteer's record. The software is used for management of Volunteer records encompassing standard operating procedures, regulations, guidelines and other training. Centralized control on rights of different users based on profile/role.

Dashboard

  • Master – MSR
  • Activity Status – On-Going, Completed, Pending
  • Cross / Participation
  • Dynamic MSK Operations
  • MSK Operations Flow – Generic
  • MSK Operations Flow – Project Specific
  • II Administrator

Master & Volunteer Management

  • Enrollment / Registration
  • MSR
  • Volunteer Enrollment
  • Volunteer Inactive / Active
  • Searching of Volunteers

Project Management

  • AE
  • DS
  • Video Consent and Review
  • Master Sheet Generation and Review Flow
  • Document Uploading
  • Card and Label Generation
  • MSR Review and Export Functionality

Lab Operations

  • Sample Collection & Tracking
  • Lab Result Entry
  • Lab Data Integration
  • Quality Control Checks

Additional Features

  • Audit Trail
  • Report Generation
  • Regulatory Compliance Logs
  • Role-Based Notifications

Administration

  • User & Role Management
  • Profile-Based Access Control
  • System Configuration
  • Activity Monitoring