Blog Posts
The Spirit of the Olympics in your TMF
The PyeongChang Olympics have begun with a flurry of inspiring headlines: Shaun White takes the gold medal and regains his crown’ Russian athletes allowed to compete despite doping controversy’ Unified Korean women’s hockey team takes the ice under united one flag’ These headlines give us hope that the Olympic Games reflects the best of humanity.…
Read MoreRomance in the TMF
I bet you are familiar with those cliché candy hearts, but did know those little hearts share some history with the pharmaceutical industry? Conversation hearts were first invented in 1847, when Boston pharmacist Oliver Chase decided he wanted to make his fortune in the apothecary lozenge fad of the mid-1800s. While Chase was working as…
Read MoreEmbracing the Risk-Based TMF
Introduction The release of the 2017 ICH GCP E6(R2) guidelines marks a paradigm shift in clinical research. Risk is mentioned no fewer than 30 times in the guidance. ICH GCP E6(R2) section 5.1 requires that the sponsor of a trial, “implements and maintains systems for quality assurance and quality and control.” 1 The EMA recognizes, that although…
Read MoreTMF Summit 2018 – Top Three Trends
It was a pleasure attending this year’s TMF Summit for many reasons. Here are the top three trends in TMF that I noticed throughout the presentations: Focus on the TMF (Trial Master File) varies greatly by company. I was surprised to see that even some of the bigger companies in attendance have only made the…
Read MoreTMF Game-Plan: Penalty Avoidance
No matter who you wanted to win the Super Bowl, we can all agree that the officiating of the game played an unusually large role in the outcome of this season. A series of key calls seemed to tilt the odds in favor of the Patriots—much to the frustration of everyone but Pats fans. The…
Read MoreMoving the Fleet Forward – Managing Complex Trial Master Files from a TMF Project Manager Point of View
Running a tight ship while utilizing a complex TMF offers many challenges. Although advanced document management systems are designed to simplify the process and minimize potential gaps, there are still many moving parts. Regardless of how advanced your TMF is, it will never remove the need for basic human interaction. With a complex TMF you…
Read MoreStaying out of the Ozarks: Financial Disclosure and the TMF
Up until the day everything changed, Marty thought he lived the perfect life. Marty had the wife, the colonial framed by a white picket fence, and two picture-perfect children. Marty was reserved, logical, and in control. Marty was a top earning financial advisor. Marty was awash in money. Unfortunately, Marty also washed money… for a…
Read MoreWhat are your TMF Resolutions?
Why do we make resolutions? The idea of starting over with the New Year is an attractive one. After a long year, it’s human nature to detour into bad habits or lose sight of the incremental steps necessary to reach an important goal. But what are the resolutions we all have in common? Since we…
Read MoreThe Twelve Days of Quality Control (QC)
We know the Holidays can be a stressful time of the year. You and your team are doing their best to meet yearend goals while hanging up the lights and fighting mall traffic. We are happy to tell you that you’ve almost reached the finish line – happily, there are fewer than twelve days until…
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