Electronic Trial Master File

Purpose-built to streamline regulatory compliance and documentation across TASS, TAES, and pivotal animal studies
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Electronic Trial Master File

Animal health clinical trials demand rigorous oversight and audit-ready documentation across diverse study types—from companion animal safety studies to livestock field trials. Cloudbyz eTMF, built natively on Salesforce, offers a unified, cloud-based solution that centralizes document and quality management across the entire study lifecycle. With built-in alignment to animal health regulatory frameworks and VICH GL9-compliant workflows, our platform helps sponsors and CROs accelerate study start-up, ensure data integrity, and remain inspection-ready at all times.

Product Features

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Regulatory Folder Structures for Animal Health Studies

Maintain structured, CVM/EMA-compliant folders specific to TASS, TAES, and multi-species studies. Preconfigured templates align with global animal health requirements and streamline document classification across protocols.

Full TMF Search

Find and retrieve documents using a search engine that's effective for both file names and metadata. Create custom list views with numerous available filters.

Review & QC Workflow

Built-in workflow routes documents through a review process with a click of a button. Assign document statuses such as "approved", "flagged", "discarded", etc. Send and receive notifications at each step of the review process. Customize the workflow based on the type and nature of a clinical research study.

Drag & Drop Upload

The drag & drop functionality in the eTMF ensures flexibility with easy movement of one or more files for uploading in the desired folder. Upload documents into a holding area for another layer of QC checks or upload them directly into a destination folder.

Automated and Configurable Metadata

The solution enables research teams and stakeholders to see content and metadata side by side to eliminate misidentified documents and incorrect metadata. It empowers them to customize, define, and store an unlimited amount of metadata, as well as enabling them to access comprehensive metadata that offers auditors, inspectors, and users, a powerful and dynamic search capability for quick retrieval of documents. Auto-populate a study’s metadata to the maximum extent possible.

Version Control & Audit Trails

Enable real-time versioning, digital signatures, and automated audit trails. Every change is tracked to ensure full transparency and compliance with GCP for animal health.

Role-Based Access and Site-Level Visibility

Ensure the right stakeholders—from sponsors and CROs to veterinary investigators—access only relevant documents. Permissions are customizable per species, region, or study phase.

Automated Alerts & Document Milestone Tracking

Trigger reminders for critical submissions such as animal health ethics approvals, owner consent logs, or protocol amendments. Keep timelines on track with real-time dashboard alerts.

Integrated Collaboration with CTMS and EDC

Seamlessly link trial master files with data from Cloudbyz CTMS and EDC modules. eTMF automatically captures documentation from monitoring visits, SDV logs, dosing deviations, and lab data entry across multi-site, multi-species trials.

Mobile-Ready for Field & Remote Access

Support document uploads and QC checks from field investigators in livestock settings or remote veterinary clinics—ensuring no data is missed in rural or high-mobility studies.

Why Cloudbyz eTMF for Animal Health?

Aligns with FDA-CVM, USDA-CVB, and EMA-CVMP regulatory frameworks
Built-in GCP support using VICH GL9 guidance
Audit-ready from protocol to post-authorization
Tailored to the complexities of species-specific animal health studies
Seamlessly integrates with your broader eClinical ecosystem

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