Trial Master File Resources

Better TMF Health from the Experts

5 Reasons your TMF Isn't Inspection-Ready (and what you can do to fix it.)

Learn to Avoid the Most Common Inspection-Readiness Mistakes

 

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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:

  • Lack of essential documents in the TMF required to enable the reconstruction of trial events and demonstrate compliance
  • Inability of sponsors to demonstrate effective oversight of clinical trial activities to fulfil their regulatory obligations
  • Insufficient functionality in the eTMF system used

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From Liability to Asset: A Trial Master File Rescue

A Case Study on the Importance of TMF Health

Phlexglobal A TMF Rescue White Paper

Learn how Phlexglobal helped a global biopharmaceutical company quickly turn a poor-quality Trial Master File into an inspection-ready asset through:

  • Complete inventory of all content and rapid, accurate conversion of documentation to usable, digital format aligned with the TMF Reference model
  • Detailed Quality Review of all documentation, with high-level heatmaps for executive overview and granular line-by-line detail for taking action
  • Full gap analysis to identify missing documentation, together with a risk-based remediation plan
  • Visibility to progress throughout the conversion to the TMF, with early identification and prioritization of critical items for corrective action

Download the Case Study

Reaching the TMF Health Zone: Expert Guidance from the TMF Authority

Reaching and Maintaining Ongoing TMF Health is Possible. We can show you how. 

Reaching the TMF Health Zone White Paper

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.

Download the White Paper

10 Things You Should Know About The New TMF Regulatory Guidance

The new EMA TMF Guidance is now in effect. Are you ready?

2019 EMA Guidlines

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. 

Download the White Paper

Recommended Trial Master File Habits by Role

Phlexglobal Inspection Readiness Habits

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.

Download the Infographic

 

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