LMK Blog

Know Your Regs: A TMF Regulatory Overview

November 19, 2019

Part 1: ICH GCP As part of a recent webinar series, LMK Clinical Research Consulting was lucky enough to host Marie-Christine Poisson-Carvajal, Head of TMF & Registry Operations at Pfizer, to discuss the main regulations that predicate the trial master file. During the webinar, Marie-Christine outlined the four most common relevant regulatory authorities and their…

Read More

TMF Horror Cliches

October 31, 2019

The Top 4 Horror Clichés Lurking in Your TMF With Halloween finally here, many of us are curling up on the couch with a bucket of candy and binge-watching horror movies. There are an abundance of these films to stream: cult classics, who-done-its, edge-of-your seat thrillers, gory slasher films, and the ever-popular zombie uprising. Some…

Read More

5 Narrative Elements That Will Reveal The Masterpiece In Your TMF

October 15, 2019

In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the…

Read More

Constant Renewal: The Perennial TMF and GDP

October 14, 2019

“Life starts all over again when it gets crisp in the fall.” This famous passage from Fitzgerald’s novel, The Great Gatsby, suggests that the fall season is a time of renewal rather than the last hurrah before the dead of winter. As we celebrate fall and contemplate winter, we should also consider the changing seasons…

Read More

Best Practices: Smart Study Start-Up Leads to TMF Success

September 19, 2019

In a recent Veeva survey, 81% of respondents reported the ongoing use of manual processes (like spreadsheets and emails) to manage study start-up.[1] More worryingly, despite the recognized need for increased clinical operations transparency and efficiency, the same survey report cites that study start-up is no faster than it was a decade ago, even considering…

Read More

Not Just a Midsummer Night’s Dream: Digital Transformation for Your TMF

September 10, 2019

Now that summer has come to an end, we are rolling up our sleeves and working hard to solve your most pressing TMF challenges. As part of our mission to ensure TMF success for all, we’re attending two important conferences: The Veeva R&D Summit, September 8th through the 10th in Philadelphia, Pennsylvania, and the Trial…

Read More

Best Practices: Contacting Trial Sites for Missing TMF Documents

August 23, 2019

Completeness is an essential component of TMF health. A TMF’s purpose is to tell the story of a clinical trial. An incomplete TMF is like a book with missing pages—even if the story is well written, it is inaccessible to any reader. In a few previous blog posts we’ve discussed how an incompleteness crisis can…

Read More

Recovery: The TMF Completeness Crisis

August 1, 2019

In our last post, we discussed the growing TMF completeness crisis. More often than ever, sponsors are discovering that upon closeout the TMF is woefully incomplete. Delays in TMF closure, as discussed in the last post, increase regulatory risk, derail regulatory submissions, and can endanger an entire project. Although a few key incompleteness mitigation strategies…

Read More

Prevention and Remediation: The Completeness Crisis

July 18, 2019

With increasing frequency, TMF stakeholders face a completeness crisis at TMF close-out.  Delays in TMF closure increase regulatory risk, derail regulatory submissions, and can endanger an entire project. Sponsors, when asked about the growing trend of TMF incompleteness, are likely to cite a challenging relationship with a CRO. Regulators, however, have little sympathy for this…

Read More