eRegulatory

Cloudbyz eRegulatory is a cloud-based solution designed to streamline the management of clinical trial documents. Built on the Salesforce platform, it provides a centralized repository for capturing, organizing, and sharing essential regulatory documentation. The platform supports paperless workflows, electronic delegation logs, and digital site binders, enabling research sites, sponsors, and CROs to maintain inspection readiness, ensure compliance, and collaborate in real time.

Features

• Centralized file management for CVs, licenses, training logs, and credentials
• Drag-and-drop document upload into structured folders
• Digital site binder management with configurable templates and DIA reference model support
• Automatic generation of electronic delegation of authority (eDOA) logs
• Training tracker with electronic signature routing
• Document generation for site green light, protocol deviations, and trip reports
• Remote access portal for external stakeholders
• Integrated eSignatures and approval workflows

Capabilities

• Real-time visibility into regulatory documentation across studies and sites
• Configurable folder structures tailored to study and client needs
• Seamless integration with eSource and other Cloudbyz modules via open APIs
• Role-based access control and audit trails for compliance
• Advanced document search and reporting for inspection readiness
• Secure cloud infrastructure aligned with global standards including 21 CFR Part 11 and HIPAA
• Scalable deployment for multi-site and global trials

Benefits

• Reduces paper-based processes and manual document handling
• Enhances collaboration among sponsors, CROs, and sites
• Improves regulatory compliance and inspection readiness
• Accelerates study start-up and site activation
• Increases operational efficiency and transparency
• Enables centralized oversight and streamlined workflows
• Supports remote monitoring and decentralized trial models