Webinars And Videos

  1. Clinical Trials And TMF 101 Learning Series: 2nd Session 11/14/2022

    The “Clinical Trials and TMF 101 Learning Series” kicks off it’s second session with three industry experts, that goes through some of the basics of clinical trials.

  2. Clinical Trials And TMF 101 Learning Series: 1st Session 9/20/2022

    Spark a deeper and broader understanding of the world of Drug Development, Clinical Trials, Regulations, the Trial Master File, and much more – for the industry novice as well as the guru.

  3. Closing The "Compliance Gap" In TMF Archiving 8/15/2022

    Discover how organizations are crossing this “compliance gap” with PhlexTMF for Viewing, an easily accessible TMF archive for internal use, audits, and inspections.

  4. Examining The "Why" And "How" Of Integrating Your eTMF And CTMS 6/24/2022

    As requirements for improved inspection readiness and quality risk management become more critical, discover the need to create a seamless integration and data flow between the eTMF and CTMS.

  5. How Standardized Terminology Can Accelerate Global Regulatory Performance 6/24/2022

    Watch this panel of regulatory experts taking part in an interactive roundtable examining the benefits of establishing standard terminology and its potential to help significantly improve regulatory quality, data accuracy, and efficiency.

  6. Get Your TMF Health Score 5/11/2022

    Introducing the TMF Health Score – an expert methodology that provides an “early warning system” to commonly overlooked issues that often lead to inspection findings.

  7. TMF Reference Model Q&A 4/19/2022

    The TMF Reference Model is at a tipping point. How will the model evolve to help manage increasing trial complexity and compliance demands? Watch the “Ask An Expert” session on demand with the co-founders of the TMF Reference Model Karen Roy and Lisa Mulcahy.

  8. Do You Know Your TMF Health Score? 3/31/2022

    For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality. View our experts explore what your TMF Health Score could be and how this can be used to achieve and maintain ongoing TMF health and inspection readiness.

  9. Is EU CTR Driving Tighter Clinical & Regulatory Integration? 3/31/2022

    The new Clinical Trials Regulation (EU) 536/2014 has raised critical questions about business process and data interactions between Clinical and Regulatory in biopharmaceutical companies. Did you know that as of 6 March 2022, there were more than 200 draft applications in CTIS?

  10. How To Ensure TMF Inspection Readiness & Compliance For A Recently Acquired Product 3/21/2022

    Concerned about inspection readiness & compliance of your TMF for a recently acquired product? The toughest TMF challenges were brought to this open forum, where Karen Roy, TMF Reference Model co-founder and, Sarah Tucker answered your questions and provided expert TMF guidance.