Electronic Data Capture (EDC)

Cloudbyz Electronic Data Capture (EDC) is a cloud-native solution built on the Salesforce platform, designed to streamline clinical data collection, management, and analysis across all phases of clinical trials. It offers a user-friendly interface, real-time monitoring, and seamless integration with other clinical systems, enabling sponsors, CROs, and research sites to accelerate study setup, improve data quality, and ensure regulatory compliance.

Features

• Study setup and reusable eCRF form libraries
• Real-time subject management and enrollment tracking
• Intelligent rules engine for data validation and protocol adherence
• Integrated randomization and medical coding (WHO-DD, MedDRA)
• Query management and source data verification (SDV)
• Adverse event and protocol deviation tracking
• Seamless integration with ePRO, eCOA, and eConsent modules
• Annotated eCRF and secure data export
• Customizable dashboards and analytics

Capabilities

• Real-time data capture and monitoring across global trials
• Configurable workflows and notifications for streamlined operations
• Open API architecture for integration with CTMS, RTSM, and external systems
• Scalable infrastructure to support large, multi-site studies
• Advanced data security with encryption, access control, and audit trails
• Full compliance with FDA 21 CFR Part 11, GDPR, HIPAA, and CDISC standards
• Accelerated study build using templates and pre-configured libraries

Benefits

• Reduces study build time and operational costs
• Enhances data accuracy and minimizes manual errors
• Improves collaboration among sponsors, CROs, and sites
• Enables faster decision-making with real-time analytics
• Ensures regulatory readiness and data integrity
• Supports decentralized and hybrid trial models
• Provides a unified platform for end-to-end clinical data management