Rethink Your Study Team to Reimagine Your TMF
For the last several decades, clinical study teams have been structured according to the Full-Service (FS) and Functional Service Provider (FSP) outsourcing models. [1][2][3] The FS and FSP outsourcing models have grown in tandem with the prevalence of CROs and have been the main catalyst for their growth. In the FP model, entire clinical studies…
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TMF 911, What’s Your Inspection Readiness Emergency?
A fire. A flood. A heart attack. These are all considered emergencies. Emergencies take a myriad of forms but share some core characteristics: They are consequential and serious events. They are unexpected and dangerous, requiring immediate action to prevent loss of life, property, or both. In the life sciences industry, the word “inspection” fits these…
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Ask the TMF Experts About That Note to File: Your Questions and Answers
Meet Sholeh Ehdaivand and Ben Rodgers. Ehdaivand and Rogers are a part of LMK Clinical Research Consulting’s family of TMF experts who share over 500 years of combined life science support experience. If you missed the second event in the Ask the Expert series, “About That Note to File…”, on Thursday, October 21st, no worries!…
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Red Flags You Can’t Ignore: More TMF Lessons from Love Is Blind
In our last blog, we introduced Love Is Blind, a Netflix reality dating show and social experiment with a twist. On the show, prospective couples meet, date, and get engaged, all without seeing each other by way of dating pods. These dating pods consist of two soundproof rooms connected by a speaker and microphone in…
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Don’t Get Left at the Altar: TMF Lessons from Love Is Blind
We’re all for some human subject research, but this experiment might go a little too far. Netflix’s season two of Love Is Blind recently premiered and promises us another ten episodes of love, tears, and dating pods all in the name of a social experiment. For the uninitiated, Love Is Blind is a Netflix reality…
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More Than Document Collection: The eTMF As the Conductor of Study Start-Up Part 2 – Ethics Submission and Approval
Study start-up (SSU) is all about speed, because in the costly world of clinical trials, time is literally money. A study conducted by the Tufts Center for the Study of Drug Development found that start-up for an individual site (pre-visit to site initiation) takes about eight months, a significant portion of the overall time and…
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More Than Document Collection: The eTMF As the Conductor of Study Start-Up Part 1 – Site ID and Selection
Study start-up (SSU) is all about speed, because in the costly world of clinical trials, time is literally money. A recent study places the cost of the median Phase III clinical trial at nineteen million dollars[1], and a typical Phase III trial may take between one and four years to complete. A study conducted by…
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Rethink Training to Reengage TMF Stakeholders
The need for TMF training is constant. Each workday your TMF team faces a barrage of new regulatory expectations, technologies, processes, documents, therapeutic areas, and clinical trial designs. With each completed study, TMF complexity grows, and the need to learn from past successes and failures becomes increasingly critical. In an environment like this, if your…
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TMF University Trial to Triumph: A Look Into Learner Experiences
It is hard to believe that the inaugural TMF University Cohort began in February of 2021. In the year since TMF University has made a splash within the TMF Community, we have had over 100 participants enroll and take part in this opportunity. We have engaged with participants and gain their feedback into the triumphs…
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