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.
Your Trial Master File is up-to-date at all times and ready for sponsors, CROs, sites and, most importantly, auditors and inspectors
Document creation, review and approvals are fully automated to ensure efficient and effective execution of all trial activities.
Every authorized trial participant – sponsors, CROs, and site – can connect to the cloud-based TMF without the need for cumbersome IT processes.
Built around the industry-standard eTMF reference model and ensures that every document expected in the file is present.