Blog Posts

LMK Clinical Research recently hosted a webinar focused on all LMK’s Services and Educational offerings Led by Janice Del Rosario, Ruby Scott, and Ben Rogers, the session reflected on lessons learned in 2024, shared strategies for success in 2025, and answered audience questions. Whether you’re navigating regulatory changes, enhancing collaboration, or refining your processes, this…

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…

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…

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…

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…

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…

Webinar Recap: TMF Quality Assurance and Auditing Practices In our Ensuring Excellence: TMF Quality Assurance and Auditing Practices webinar, Janice Del Rosario, Director of TMF Services at LMK Clinical Research, and Ruby Scott, Associate Director of TMF Services experienced – industry professional, led an insightful discussion on TMF quality assurance and auditing best practices. With…

Trial Master File (TMF) Management Resource Guide at Startup This resource guide outlines essential steps and best practices for effectively managing the Trial Master File (TMF) at the start of a clinical trial. It focuses on the early development of key documents, expectations for stakeholder collaboration, and ongoing quality control and metrics reporting. 1. Early…

Happy Halloween from the team at LMK! 🎃 We’ve been carving pumpkins, stashing away candy (some of which might actually make it to trick-or-treaters), and breaking out our best zombie moves every time “Thriller” starts up on our playlist. Halloween is spooky for many reasons, but here’s a frightening thought: Thriller came out nearly 35…