eTMF
ClinVigilant® eTMF is a powerful application that connects sponsors, CRO staff, and site resources with automations to create, manage, and track the Trial Master File (TMF).
Administering a clinical study’s TMF goes far beyond just managing the creation, review and approval of TMF content. Every study has its own data requirements and complexities. Handling all contributor and participant interactions gets overwhelming quickly.
With ClinVigilant® eTMF you gain real-time visibility into the status of all clinical activities. Based on the TMF Reference Model. Our solution simplifies the management of all the documents, tasks, milestones and activities that are required during a clinical trial.
Key Benefits
Inspection Ready
Your Trial Master File is up-to-date at all times and ready for sponsors, CROs, sites and, most importantly, auditors and inspectors.
Integrations and automations
Automate document creation, review and approval to ensure efficient and effective execution of all trial activities. We integrate with most of the best well-known eClinical platforms
Connect all trial personnel
Manage access permissions and keep all relevant stakeholders – CROs, sites and sponsors - connected remotely.
Regulatory compliant
Built around the industry-standard eTMF reference model.
Key Features
New
Sites
Sites get create automatically, based on Study design and the TMF Reference Model.
Document &
Forms
Combine documents and forms to accelerate study processes.
Inspect &
Verify
Inspect, verify and identify gaps in eTMF contact at any time.
One
Location
Ensure availability of all trial documents, in one location
Review &
Approval
Automate creation, review and task approval with configurable workflows.
Permissions &
Access
Accessible by all authorized trial staff - sponsors, CROs and site owners.
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