TMF Trend Analysis: Top 5 Inspection-Readiness Mistakes (and how to fix them)

Tuesday, April 7, 2020 | 10am Eastern  /  3pm GMT / 4pm Central Europe

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.

Join Eldin Rammell 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.

Webinar attendees will learn:

• Ways to identify the signs of a poor-quality Trial Master File – and correct them before problems become compounded
• How to evaluate the TMF structure and plan, together with related processes, to ensure a full understanding of the scope of the TMF across a sponsor organization, CROs, and investigator sites
• Proven ways to develop an inspection-readiness culture across functional areas, to improve for example the timely filing of essential documents