TMF MANAGEMENT
TMF MANAGEMENT
Trial Master File Management
Dobbs Consulting can collect, track, compile, and maintain essential regulatory documents with either an electronic or paper TMF system. Our Tennessee office houses fireproof cabinets for storage of original documents for our clients' trial master files. Our clients are given access to their central files which receive real-time updates. All original documents and/or electronic files are sent to the client at specified intervals, if so requested.
Dobbs Consulting's in-house Regulatory Specialist will work closely with the investigative sites during study start-up to expedite the essential regulatory document collection and IRB/EC submission processes. Documents will be tracked for compliance on a comprehensive Microsoft Excel spreadsheet which will be regularly updated and disseminated to the study team in the form of a customizable status report.
Dobbs Consulting utilizes KnowledgeTree document management system and Barracuda backup applications to enhance our document management storage in the most safeguarded yet efficient manner available. KnowledgeTree is a secure web-based application that will allow documents to be uploaded and shared. This will benefit and improve business productivity without the hassle and security issues of sharing information through e-mail. The data that is uploaded will be easily accessible to our clients from their PC, Mac, or handheld anytime, 24/7.
We have also implemented a double-protected server backup service through Barracuda Networks. This backup service provides a full load, on-site data backup combined with off-site data storage. This completes the “best of both worlds” scenario; on-site backup will permit faster restore times, and off-site storage will be relied upon for disaster recovery. Implementing these cutting edge solutions is our way of providing the ultimate in eTMF management to our clients.