Based on helping companies pass hundreds of inspections by regulatory agencies worldwide, the guide will help you identify and correct those areas most often flagged by inspectors, including:
Learn how Phlexglobal helped a global biopharmaceutical company quickly turn a poor-quality Trial Master File into an inspection-ready asset through:
For over 20 years, Phlexglobal has helped organizations from Top 20 biopharmaceutical companies and the world’s largest CROs, to small biotechs and specialty CROs, achieve Trial Master File quality, completeness, and timeliness. Dedicated solely to TMF best practices in both software and services, we have a unique perspective on the core requirements to achieving ongoing TMF Health and inspection-readiness: what we refer to as the “TMF Health Zone.”
We have summarized this extensive knowledge into core principles, to provide pragmatic guidance on how to best reach the TMF Health Zone.
The European Medicines Agency (EMA) guidance on Trial Master Files took effect on June 6, 2019 and promises to have far-reaching impacts on an organization’s TMF processes, technology, and best practices – as well as related departments and systems.
Phlexglobal is offering this free guide by renowned TMF expert Eldin Rammell to help you better understand the impact this can have on your TMF management processes.
To do inspection-readiness well and make it stick, you need a plan that goes beyond learning about the regulations and writing new procedures, more than developing metrics and creating dashboards, more than creating another online learning module. You need to consider human behavior and how we fail to develop habits that take care of our future selves, or in this case, our TMF deliverables.
This infographic outlines cues and actions, rewards, and routines for key positions relevant to TMF Health. To learn more about creating good TMF Habits, read our blog How to Transform TMF Quality Guidelines into Inspection-Readiness Habits or watch the on demand webinar featuring TMF expert Mark Webb.