Blog Posts

Training is the cornerstone of Trial Master File (TMF) excellence. A well-trained team ensures compliance, enhances operational efficiency, and maintains inspection readiness. However, without a structured approach, training can be inconsistent, outdated, or ineffective. Investing in comprehensive TMF education programs is crucial for professionals and organizations striving for excellence. One of the biggest challenges in…

Building a Solid, Compliant, and Inspection-Ready TMF A well-structured, regulatory-compliant Trial Master File (TMF) is the backbone of any clinical trial. It ensures reliability, credibility, and continuous inspection readiness, meeting evolving regulatory expectations. With increased scrutiny from health authorities and the push for digital transformation, sponsors and CROs must proactively strengthen their TMF strategy. Here’s…

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…