Webinars And Videos

  1. eTMF Innovation 8/25/2021

    Watch the available video to see how AI-Powered Automation can streamline your Trial Master File Management.

  2. Functional Work Streams: Operationally Preparing Your Teams For Successful TMF Inspections 7/14/2021

    Inspection readiness is all about preparation. Not just having your documents in order, but also your team. In this session, seasoned TMF expert McKenzie Knudson will share a proven approach to getting your team ready for inspections.

  3. Crossing The TMF Compliance Gap With Inspection-Ready Access For Closed Studies 4/30/2021

    Your drug study is closed, you need inspection-ready access to the Trial Master File, but your CRO is ready to get the TMF out of their system and wants to send you a zip folder full of documents. What do you do? In this session, we explore an innovative new way to ensure your TMF stays secure while remaining accessible to audits and inspectors so you can focus on getting your drug to market and not on finding documents. 

  4. Taking A Risk-Based Approach To An Inspection-Ready Audit Trail 2/10/2021

    Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspection.

  5. Overcoming TMF Management Challenges For Small And Mid-Sized Companies 2/10/2021

    Maintaining an inspection-ready Trial Master File is becoming increasingly burdensome, even for teams with significant resources. In this webinar our experts walk through a new, full-service TMF management approach implemented by smaller biopharmaceutical companies. By adopting a fixed-fee, turnkey model encompassing everything required for ongoing TMF health, these organizations are achieving high-quality TMF compliance – with far less effort.

  6. The Journey From File To Trial: Automating Regulatory To TMF 2/9/2021

    In this webinar, we explore the value of automation between the Trial Master File (TMF) and Regulatory solutions.  This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data entry.