Posts by Isaiah Howard
LMK Veeva Capabilities
TMF optimization starts long before system configuration. This guide breaks down how TMF assessments, Veeva Vault alignment, and team training work together to build a stronger foundation for compliance, quality, and long-term success. Whether you’re preparing for an upcoming inspection or addressing known TMF challenges, these practical insights help your team move forward with clarity…
Read MoreUnlocking TMF Success: The Power of Expert Consulting
Read MoreBuild TMF Skills That Stick
No two TMF careers look the same — and your path to success shouldn’t either. That’s the idea behind TMF University, a flexible and accredited program designed to support learners at every level of experience, from those just stepping into the TMF world to professionals ready to take on leadership roles. One thing that sets…
Read MoreFrom Draft to Final: Essential Records Done Right
5 Steps to Avoid Inspection Findings
Avoiding inspection findings starts long before an audit begins. This quick guide outlines five practical steps TMF teams can take to strengthen compliance, reduce risk, and stay inspection-ready at every stage of the trial. Whether you’re working with internal teams or external partners, these tips help ensure your Trial Master File meets regulatory expectations. …
Read MoreMen’s Mental Health Needs a Trial Master File Approach
Men’s mental health continues to be one of the most overlooked areas in public health. But the clinical research world offers a powerful model for change. The evolution of informed consent and the structure provided by the Trial Master File (TMF) remind us that lasting impact starts with clear communication, accountability, and ethical responsibility. This…
Read MoreTMF University: Town Hall
Read MoreBridging Gaps: Strengthening Collaboration in the TMF
TMF Migration and Consulting Case Study
Background and Challenge A biotech company engaged LMK Clinical Research Consulting for support with a Trial Master File (TMF) migration from another eTMF vendor to TI. The scope included consulting hours as a contingency. The client’s primary point of contact, lacked TMF and clinical operations experience. Combined with poor CRO performance, this created delays and…
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