ArisGlobal Announces Cloud-based Electronic Trial Master File (eTMF) Solution to Better Meet GCP Regulatory Requirements and Reduce Time to Submission


Applied Clinical Trials

STAMFORD, CT- April 13, 2015- ArisGlobal, a leading provider of solutions to the life sciences industry, has today announced the availability of agFileMaster; a Cloud-based electronic trial master file (eTMF) solution that serves as a centralized, global repository for managing all clinical trial-related documents in accordance with GCP standards and applicable regulatory requirements.

agFileMaster can be deployed either as a stand-alone solution or unified as part of ArisGlobal’s Clinical Trial Management System (CTMS).  Life science organizations can overcome the complex burden of collecting, organizing and tracking the vast amount of essential trial documents from a multitude of disparate content management repositories with a single solution that provides real-time, controlled access to essential trial documentation.

Fully validated, agFileMaster supports the DIA TMF Reference model and is 21 CFR Part 11 compliant, helping to ensure the TMF file structure and organization is ready for audit and inspection. Full, context-sensitive document management capabilities and integrated workflows support and streamline key business processes to speed up site set-up and initiation and ensure patient recruitment can start as early as possible.

“Many of today’s current eTMF solutions are falling short of what is needed,” said Simon Sparkes, Executive Vice President, Product Strategy at ArisGlobal. “We need to be able to more than just organize documents.  A modern eTMF needs to be able to identify documents required for each country and entity, identifing missing documents while allowing online exchange with sites.  Ultimately, the aim of any eTMF is to support a submission/approval process.  Our eTMF fully supports the tracking of all documents required for approval as well as tracking the submission itself.  Of course an eTMF becomes truly effective when integrated with a CTMS. agFileMaster goes beyond the limitations of traditional integration of incompatible vendor solutions and is part of our fully unified clinical operations platform including agClinical CTMS ”

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