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eSourceCloudbyz

Cloudbyz eSource is a cloud-based solution that captures clinical data directly at the source, streamlining trial workflows and improving data quality. It reduces paper-based processes, supports real-time monitoring, and ensures compliance with FDA 21 CFR Part 11, GCP, GAMP5, and HIPAA standards.

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Product details

eSource

Cloudbyz eSource is a cloud-based solution designed to capture clinical data directly at the source and manage it efficiently throughout the clinical trial lifecycle. Built on the Salesforce platform, it enables research teams to collect, analyze, and manage data of varying complexity in real time. The platform supports direct data capture, integrates with other Cloudbyz modules, and ensures full compliance with global regulatory standards such as FDA 21 CFR Part 11, GCP, GAMP5, and HIPAA.

Features

  • Easy study setup with protocol-driven configuration
  • Patient visit scheduling and procedure tracking
  • Subject enrollment tracking with real-time dashboards
  • Integrated eConsent and eCRF modules
  • Direct data capture (DDC) from mobile and desktop devices
  • Integration with eCOA, ePRO, and eDiary
  • Built-in patient recruitment and safety tracking
  • eRegulatory document management integration

Capabilities

  • Real-time data collection and monitoring across sites
  • Centralized platform for managing all study-related data
  • Configurable workflows for study setup and visit planning
  • Role-based access and secure data handling
  • Automated visit window calculations and calendar scheduling
  • Scalable infrastructure for global, multi-site trials
  • Full audit trails and compliance with regulatory standards
  • Seamless integration with CTMS, EDC, and other clinical systems

Benefits

  • Eliminates up to 90% of paper-based processes
  • Improves data quality by up to 80%
  • Reduces site effort per patient by approximately 8 hours
  • Cuts source data verification time by about 2 hours per patient
  • Increases overall site efficiency by up to 65%
  • Enhances collaboration and visibility across study teams
  • Accelerates study timelines and reduces operational costs
  • Supports inspection readiness and regulatory compliance
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