Electronic Data Capture

Cloudbyz Electronic Data Capture (EDC) is a cloud-based, user-friendly solution designed to efficiently capture and manage clinical data throughout the lifecycle of a clinical trial. It supports clinical research teams in collecting, analyzing, and managing data of varying complexity and size.

The platform offers a rapid study setup with a point-and-click interface, allowing users to build forms and navigate screens for data collection and analysis with ease. It includes a comprehensive eCRF form library for creating simple to complex forms, facilitating efficient data collection, monitoring, and cleansing.

Key Features

• Rules Engine: Create complex forms with multiple validation rules at the field level. Define data validation checks and messages, and assign actions for data entry errors.
• Subject Management: Track enrollment at various levels and manage study arms and visit schedules.
• Visit Management: Define procedures, visits, and payment policies, with projected visit windows and schedules.
• eConsent: Replace paper-based consent with interactive, multimedia-enabled consent on mobile devices, integrated with real-time tracking.
• Randomization: Handle complex randomization schemes with stratifications and multi-arm studies, using pre-integrated algorithms.
• eCRF: A cloud-based solution for rapid data collection and cleaning, compliant with 21 CFR part 11, featuring data backup, security, and multimedia support.
• eCOA/ePRO/eDiary: Capture clinical-outcome data through user-friendly interfaces, supporting multimedia content and patient reminders.
• AE and PD Data Capture: Monitor and report safety events and protocol deviations in real-time.
• Risk-Based Monitoring: Identify data discrepancies and set up risk-based monitoring workflows with key risk indicators.
• Investigator Portal: A single platform for clinical research sites to manage eCRFs, report deviations, maintain documentation, and communicate with stakeholders.
• Patient Portal: Seamlessly integrated for patient engagement and data collection.