eCDMS

E-Clinical Data Management System

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About eCDMS

Introduction 

E-Clinical Data Management System is an intranet and internet-based software and is accessible by authorized users only. E-Clinical Data Management System is an Electronic Data management System to provide electronic data set-up to update, maintain volunteer’s historical records information.
E-Clinical Data Management System is compliant with operational & functional requirements

System overview

E-Clinical Data Management System is a comprehensive suite of application to manage the entire Volunteer’s record. The software is mainly used for Management of Volunteer’s record encompassing standard operating procedure, regulations, guidelines and any other training.

Centralized control on rights of different based on profile/roles.

This system comprises for Managing of Volunteer’s related all the activities details are below:

  • Dashboard
    • Master - MSR
    • Activity Status – On-Going, Completed, Pending
    • Cross Participation
    • Dynamic MSR Operations
      • MSR Operations Flow - Generic
      • MSR Operations Flow - Project Specific
  • IT Administrator
 
  • Master
    • Enrollment/Registration
    • MSR
  • Volunteer Management
    • Volunteer Enrollment
    • Volunteer Inactive / Active
    • Searching of Volunteers
  • Lab Operations
  • Additional Features
    • Audit Trail
    • Report
  • Project Management
    • AE
    • DS
    • Video Consent and Review
    • Master Sheet Generation and Review Flow
    • Label Generation
    • Document Uploading
    • Card and Label Generation
    • MSR Review and Export Functionality
 

Our Expertise Includes:

  •  Computer System Validation (CSV): Compliance with FDA 21 CFR Part 11, GAMP 5, and other industry standards.

  •  Equipment & Process Validation: Ensuring operational efficiency and regulatory adherence.

  •  Software & Application Validation: Verification and qualification of critical software solutions.

  •  Data Integrity & Compliance Audits: Assessing and mitigating risks to maintain regulatory compliance.

  •  Qualification Services: IQ, OQ, PQ execution for laboratory, manufacturing, and IT systems.