Constant Renewal: The Perennial TMF and GDP
“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 MoreBest Practices: Smart Study Start-Up Leads to TMF Success
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 MoreNot Just a Midsummer Night’s Dream: Digital Transformation for Your TMF
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 MoreBest Practices: Contacting Trial Sites for Missing TMF Documents
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 MoreRecovery: The TMF Completeness Crisis
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 MorePrevention and Remediation: The Completeness Crisis
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 MoreTransform Your TMF Team: The Rewards of TMF Training
Your choice of eTMF system, performance metrics, quality system, and any other TMF initiative are critical, but ultimately the success of your TMF is secured through the engagement and competency of your TMF team. At LMK, we believe the most important features of your TMF are people and that innovative TMF training is as important…
Read MoreThe Four P’s of Migration
Change isn’t easy. Although your current TMF system may no longer align with your team’s goals, the prospect of migrating to a new eTMF system can be intimidating. Selecting the correct eTMF system for your team’s needs is only an initial step. Deployment of a new eTMF system requires training, updated processes and SOPs, complete…
Read MoreThe Mindful TMF: Acceptance and Letting Go
About LMK’s Mindful TMF Series Your palms are sweaty. Your pulse races when you hear the news. You’d do anything for a few more hours to prepare and you might work all night. It’s TMF inspection day and now it’s too late to make a meaningful change. At LMK Clinical Research Consulting, we know the…
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