eRegulatory

Cloudbyz eRegulatory is a comprehensive cloud-based solution designed to manage all clinical trial documents efficiently. It provides a centralized repository for capturing, managing, sharing, and storing essential trial documents, ensuring that research sites remain inspection-ready and can collaborate in real-time with study partners.

The solution streamlines regulatory workflows by offering paperless binders and an electronic delegation log. It supports centralized file management, allowing sites to handle common documents such as CVs, medical licenses, and training logs in one location. The drag-and-drop upload feature facilitates easy file movement into the electronic trial master file folder.

Product Features

• Centralized File Management: Aligns common documents to studies automatically upon setup.
• Drag & Drop Upload: Simplifies file uploads into the eTMF.
• Document Generation: Facilitates easy creation of documents like protocol deviations and trip reports.
• Digital Site Binder Management: Offers template-based and configurable binder structures.
• Electronic DOA: Automatically generates delegation of authority logs with eSignatures.
• Training Tracker: Monitors training logs and routes them for electronic signatures.
• Remote Access: Allows external stakeholders to access and download regulatory documents.
• eSignatures: Supports 21 CFR part 11 compliant electronic signatures.
• Approvals: Configurable workflow and approval processes.
• Integration with eSource: Seamlessly integrates with CTMS and patient recruitment capabilities.

Built on the Salesforce platform, eRegulatory is highly configurable and scalable, meeting industry regulatory requirements such as SOC1, SOC2, HIPAA, and GDPR. It offers workflow automation, real-time collaboration, and customizable reports and dashboards. Open APIs enable integration with external systems, enhancing its functionality and adaptability to specific needs.

Overall, Cloudbyz eRegulatory empowers clinical research teams to manage their documentation processes efficiently, ensuring compliance and facilitating seamless collaboration across all stakeholders involved in clinical trials.