eTMF

Cloudbyz Electronic Trial Master File (eTMF) is a cloud-based document management solution designed for clinical trial sponsors, CROs, sites, and monitors. Built on the Salesforce platform, it provides a centralized repository for all clinical trial documents — including files, images, and associated information — enabling teams to digitally capture, manage, share, and store trial-related content with real-time visibility across all stakeholders.

The solution converts paper-based trial master files into an electronic, cloud-based model and is available alongside Cloudbyz CTMS. It supports multi-device configurability and is designed to keep organizations inspection-ready while streamlining collaboration between sponsors, CROs, and investigative sites throughout the clinical trial lifecycle.

TMF Reference Models and Structure

• Supports both standard and custom TMF reference models, including the latest version of the widely used built-in DIA reference model.
• Allows users to add or remove folders from built-in models and apply them directly to a study as required by a study-specific TMF plan and index.
• Automatically generates the folder structure when a new study is added, reducing manual setup effort.

Document Upload and Management

• Drag-and-drop functionality enables easy movement and uploading of one or more files into desired folders.
• Documents can be uploaded into a holding area for an additional layer of QC checks, or uploaded directly into a destination folder.
• Supports creation, uploading, classification, approval, and indexing of documents in just a few clicks.

Search and Retrieval

• Full TMF search capability allows users to find and retrieve documents using both file names and metadata.
• Custom list views can be created with numerous available filters to refine search results.
• Comprehensive metadata access provides auditors, inspectors, and users with a powerful and dynamic search capability for quick document retrieval.

Review and Quality Control Workflow

• Built-in workflow routes documents through a review process with a single click.
• Document statuses such as "approved," "flagged," and "discarded" can be assigned at each stage.
• Notifications are sent and received at each step of the review process to keep stakeholders informed.
• Workflows can be customized based on the type and nature of the clinical research study.

Metadata Management

• Enables research teams and stakeholders to view content and metadata side by side, eliminating misidentified documents and incorrect metadata.
• Users can customize, define, and store an unlimited amount of metadata fields.
• Auto-populates a study's metadata to the maximum extent possible, and supports auto-naming of documents.

Indexing and Audit Trails

• Builds a real-time audit trail that documents the complete history of how a document reached its current state.
• Audit trails are an integral feature for data validation and security, supporting inspection readiness.

ISF Reconciliation

• Connects sponsor and site operations through the Cloudbyz Investigator Portal, allowing sites and CRAs to upload essential documents directly into the system.
• Sites can maintain Investigator Site Files (ISFs) within the system, which are seamlessly connected to the TMF folder by folder.

Notifications and Communication

• Provides timely, contextually relevant notifications to prompt completion of tasks such as document reviews.
• Supports cross-functional team communication through built-in chat functionalities.
• Rule-based automatic notifications can be configured to ensure timely action on missing or expiring documents.

Reports, Dashboards, and Analytics

• eTMF reports and dashboards allow users to view and assess critical metrics including quality, timeliness, and completeness — providing a real-time view of eTMF health.
• Workflows, tracking, alerts, and reports can be established in advance and automated as required.
• Users can subscribe to key reports and receive them directly in their inbox at a chosen time and date.

Access Control and Security

• Customizable role-based access controls allow management of permissions at the study, site, and user level.
• Separate permission sets can be granted for monitors, auditors, and internal users.
• Built on the Salesforce cloud platform, the solution delivers the highest levels of data security with granular user access management.

Cloudbyz eTMF integrates with various clinical trial management systems, enabling organizations to control their entire process from a single location and strengthen documentation control across multiple systems. The platform is ISO 9001:2015 and ISO 27001:2022 certified, reflecting its commitment to quality and information security standards.