As regulatory agencies continue to issue updated TMF guidance and tighten enforcement around the Trial Master File, expect an increase in critical findings like the one a sponsor received from a major regulatory agency: “There were many documents missing from the eTMF, for example, signature sheets, correspondence, emails and previous versions of documents.”
The result? Significant, unforeseen manual effort and cost on the part of the sponsor and their CRO – and a lengthy delay to the sponsor’s drug submission. Watch this on demand webinar to get practical tips on how to improve inspection-readiness in your organization – avoiding the most common mistakes organizations make regarding TMF quality, completeness, and timeliness.
Head, Quality Assurance
With over 30 years experience in the field of records management, my objective is to help Phlexglobal clients to improve working practices, processes and systems through better use of their information assets.... their records! Improvements are achievable through increased efficiency, better regulatory, legal or fiscal compliance, more effective processes. Records management can be a pivotal factor in achieving these improvements.