eTMF

ClinVigilant eTMF is an Electronic Trial Master File solution designed for sponsors, CROs, and site personnel involved in clinical trials. Built around the TMF Reference Model, it centralises the management of documents, tasks, milestones, and activities required throughout a clinical study, providing real-time visibility into the status of all clinical activities.

The solution addresses the complexity of administering a study's TMF beyond basic document management, including contributor interactions, multi-stakeholder coordination, and inspection readiness. It supports remote access for all relevant trial personnel and automates key document lifecycle processes.

Key Benefits

• Inspection readiness: The Trial Master File is kept up-to-date at all times, making it accessible and ready for review by sponsors, CROs, sites, auditors, and regulatory inspectors.
• Integrations and automation: Automates document creation, review, and approval workflows. Integrates with a range of established eClinical platforms.
• Stakeholder connectivity: Manages access permissions and keeps CROs, sites, and sponsors connected remotely.
• Regulatory compliance: Built around the industry-standard eTMF Reference Model.

Key Features

• Multi-site support: Allows addition and configuration of multiple trial sites as needed.
• Document and form management: Supports uploading and organising all trial-related documents and forms.
• Remote inspection and gap identification: Enables remote inspection, verification, and identification of document gaps at any time.
• Centralised document repository: Stores all trial documents in a single location with integrated quality review processes for easy accessibility.
• Review and approval workflows: Provides customisable workflows to manage the creation, review, and approval of tasks and documents.
• Permissions and access control: Allows granular management of permissions and access at the document and folder level.

ClinVigilant eTMF is offered as part of the eClinical Suite and supports integration with widely used eClinical platforms, enabling coordinated trial management across distributed teams and organisations.