Administering a clinical study’s TMF goes far beyond just managing the creation, review and approval of TMF content. Every study has its own information requirements and complexities. Handling all contributor and participant interactions gets overwhelming quickly. Clinvigilant eases these burdens. With the Clinvigilant® eTMF solution, you gain real-time visibility into the status of all clinical activities. Based on the TMF Reference Model, the 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

Complete, Connected
Processes

Document creation, review and approvals are fully automated to ensure efficient and effective execution of all trial activities.

Connects
Everyone

Every authorized trial participant – sponsors, CROs, and site – can connect to the cloud-based TMF without the need for cumbersome IT processes.

Fully

Built around the industry-standard eTMF reference model and ensures that every document expected in the file is present.

Key Feature

NEW SITES

Sites get create automatically, based on Study design and the TMF Reference Model.

DOCUMENTS & FORMS

Combine documents and forms to accelerate study processes.

INSPECT & VERIFY

Inspect, verify and identify gaps in expected eTMF contact at any time.

ONE LOCATION

Ensure availability of all trial documents, in one location, with baked in quality review processes.

REVIEW & APPROVAL

Automate creation, review and approval tasks with configurable workflows.

PERMISSIONS & ACCESS

Accessible by all authorized trial participants – sponsors, CROs and site owners.