Featured Articles

  1. A Blueprint For Genuine Partnership In TMF Improvement 12/5/2023

    Embrace the evolving significance of Trial Master Files by fostering strong partnerships, as exemplified in this collaborative model, to not only optimize TMF management but also strengthen key aspects of your organization.

  2. Rewind The Clock And Take TMF Back To Basics 12/4/2023

    Consider the evolution of Trial Master Files (TMF) in clinical trials when tackling the paradigm of maintaining simplicity while embracing technology.

  3. A Model For Improving TMF Management 10/30/2023

    Get pragmatic details of what it took to build a successful partnership, why it has become a model for other departments within Regeneron, and lessons learned you can apply in your organization.

  4. How To Reduce Risk And Effort When Migrating A TMF 10/19/2023

    Utilize this summary of key tips, checklists, and lessons learned to mitigate the risks and efforts associated with migrating a trial master file.

  5. Improving Quality And Efficiency In TMF Document Processing 10/19/2023

    By adhering to the principles outlined in this article, learn how teams can be better enabled to carry out efficient, high-quality processing of documents throughout the entirety of a study.

  6. Removing Chaos In 3 Steps: A Guide To Planning TMF Migrations 9/18/2023

    Knowledge and planning are the keys to successful trial master file migrations. Utilize this guide when navigating the most important part of any TMF migration: project scoping and planning.

  7. Solved: Is Our TMF Missing More Than We Know? 8/22/2023

    Take a closer look at the heatmap analysis process and explore how this tool can help study teams ensure TMF health and reduce risk.

  8. Be Inspection-Ready: Risk-Based TMF Quality Checks And Reviews 8/21/2023

    Roughly one-third of participants disclosed adherence to a system for evaluating TMF quality. Use this information and other insights to improve TMF quality and inspection readiness.

  9. Building A Strong Sponsor-CRO Relationship For An Inspection-Ready TMF 6/15/2023

    Get the highlights from a February 2023 FierceBiotech webinar, where pharmaceutical company Chiesi and CRO CROMSOURCE shared best practices from their decades-long partnership.

  10. Practical Steps To Reduce Your TMF Inspection Risk 6/15/2023

    Take these pragmatic steps outlined by compliance experts to make the most of an upcoming trial master file inspection – regardless of your state of preparation.