Verial eTMF

Verial eTMF is an electronic trial master file (eTMF) solution designed by Verial to provide a secure environment for managing trial-related documents and ensuring inspection readiness throughout the clinical trial lifecycle. According to the vendor, this solution is suitable for companies of all sizes, from small biotech startups to large pharmaceutical companies. It is utilized by clinical research professionals, clinical operations managers, clinical trial coordinators, clinical data managers, and regulatory affairs professionals across various industries.

Key Features

eTMF Document Management: Verial eTMF is said to provide a secure environment for managing trial-related documents throughout the clinical trial lifecycle. According to the vendor, users can easily upload, organize, and track documents, ensuring inspection readiness and compliance.

Document Collaboration and Review: Verial eTMF enables seamless collaboration and review of trial documents among study team members. The vendor claims that users can assign tasks and permissions to individuals or groups, facilitating document review and approval processes.

Document Workflow Management: Verial eTMF offers customizable workflows to streamline document management processes. According to the vendor, users can define and automate document routing and approval workflows based on study-specific requirements.

Document Compliance and Inspection Readiness: According to the vendor, Verial eTMF helps ensure compliance with regulatory requirements and industry standards. The system is said to support the organization and maintenance of essential documents, investigator files, and regulatory submissions.

Document Access Control and Security: Verial eTMF employs robust access control mechanisms to protect sensitive trial documents. The vendor states that user roles and permissions can be configured to restrict access to specific documents and functionalities.

Integration with Other eClinical Systems: According to the vendor, Verial eTMF integrates seamlessly with other eClinical systems, such as electronic data capture (EDC) and clinical trial management systems (CTMS). Integration allows for the automatic exchange of data and documents, eliminating the need for manual data entry and ensuring data consistency.

Version Control and Audit Trail: Verial eTMF supports version control, allowing users to manage document revisions and maintain an audit trail. According to the vendor, this ensures traceability and accountability throughout the document lifecycle.

Document Categorization and Tagging: Verial eTMF allows users to categorize and tag documents for easy searching and retrieval. According to the vendor, this enhances document organization and facilitates efficient document management.

Real-time Commenting and Feedback: According to the vendor, Verial eTMF enables real-time commenting, feedback, and annotations on documents, promoting efficient collaboration and communication among study team members.

Customizable Dashboards and Reports: Verial eTMF provides customizable dashboards and reporting capabilities to monitor document completeness, workflow progress, and compliance with regulatory guidelines. The vendor claims that this allows for proactive management and decision-making.