eSource

Cloudbyz eSource is an advanced cloud-based solution designed to capture clinical data directly at the source and manage it efficiently throughout the clinical trial lifecycle. It enables research teams to collect, analyze, and manage clinical data of varying complexity and size, ensuring compliance with essential regulatory standards such as FDA 21 CFR Part 11, GCP, GAMP5, and HIPAA.

By utilizing Cloudbyz eSource, users have significantly reduced paper-based processes by 90%, improved data quality by 80%, and decreased overall process time by 37%. For each study, the time spent on one patient by the site can be reduced by 8 hours, and source data verification time can be cut by about 2 hours per patient. The integrated platform offers a 65% increase in efficiency for managing clinical trial operations at the site.

Product Features

• Easy Study Setup: Configure and visualize studies according to protocol requirements, accessing details like phase, type, therapeutic area, and outcomes.
• Patient Visits: Define procedures, subject visits, and payment schedules based on budgets and protocols, with projected visit windows calculated per plans.
• Subject Enrollment Tracking: Monitor enrollment status throughout the trial, providing insights and KPIs to keep studies on track.
• eConsent: Replace paper-based consent with interactive, multimedia-enabled documents on mobile devices, integrated for real-time enrollment tracking.
• eCRF: A cloud-based solution for rapid data collection and efficient data cleaning, reducing data management efforts and costs.
• Integrated Patient Recruitment: Offers study listing on public websites, patient portals for registration, and eConsent.
• Integrated with Safety: Integrates with pharmacovigilance software for advanced analytics and data integrity.
• Direct Data Capture (DDC): Capture clinical data in real-time, integrating with EMR/EHR and diagnostic devices.
• eCOA, ePRO & eDiary: Replace paper-based outcomes with mobile-friendly solutions for capturing clinical outcome data.
• eRegulatory: Integrated solution for saving clinical trial documents directly into eRegulatory upon review.
• eSignature: Supports FDA 21 CFR part 11 compliant eSignatures, eliminating paper documents.
• Enable Remote Monitoring & SDV: Efficient source data verification to ensure data accuracy and completeness.
• Sponsor / CRO Portal: Provides real-time visibility on study progress and quality controls for sponsors and CROs.