Posts by Isaiah Howard
2024 TMF Recap: Driving Success Through Education & Services
Unlocking the Future of TMF Professionals Through TMF University
The Purpose of TMF University In an era where regulatory scrutiny of Trial Master Files (TMF) is more stringent than ever, ensuring that TMF management professionals have a comprehensive understanding of regulatory and industry requirements has become a non-negotiable priority. As the backbone of clinical trial documentation, the TMF must be audit-ready and compliant at…
Read MorePaving the Way to 2025: How TMFU and LMK Consulting Set the Stage for the Future
As we reflect on 2024 and look ahead to 2025, it’s clear that LMK Clinical Research is leading the charge in redefining Trial Master File (TMF) excellence. Through innovative education programs and consulting services, LMK has not only addressed the evolving needs of the clinical trial landscape but has also set the stage for future…
Read MoreReady for 2025? Your TMF QC Checklist for the New Year
The holiday season is the perfect time to reflect on growth, share gifts, and prepare for the year ahead. For your Trial Master File (TMF) team, there’s no greater gift than the knowledge and skills to achieve TMF excellence. Much like trimming a tree or building a gingerbread house, TMF Quality Control (QC) requires careful…
Read MoreJingle All the Way to TMF Success: A Year-End Celebration
With lights twinkling in the trees, wreaths adorning doors, and Mariah Carey’s ‘All I Want for Christmas’ playing everywhere, the holiday season is in full swing—and it’s the perfect time to reflect on the incredible strides in TMF education and TMF services throughout 2024. This year, TMF University celebrated a major milestone with its highest…
Read MoreLaying the Groundwork for Effective TMF Planning and Setup
How a Robust TMF Drives FDA Submission Success
The Trial Master File (TMF) has always been a cornerstone of clinical research, but with the FDA’s recent guidance on standardized electronic submissions for NDAs and BLAs, its importance has reached new heights. This guidance not only streamlines the submission process but also enhances inspection readiness, compliance, and data integrity. Let’s explore how these updates…
Read MoreWebinar Recap: Insights from the CDISC and TMF US Interchange Conference
Webinar Recap: Insights from the CDISC and TMFUS Interchange Conference We kicked off with Cassandra Andrade, who warmly welcomed the attendees and introduced her co-hosts, Gillian Gittens and Ben Rogers. Cassandra acknowledged familiar faces from recent events, like the CEDA’s conference, underscoring the vibrant network joining this webinar. Ben Rogers shared critical takeaways from the…
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