Blog Posts
Is Your TMF Ready For GDPR? Part One: Know Your Roles
This post is the first in a two-part series outlining how the new European Union General Data Protection regulation could impact your Trial Master File. Since 1995, EU Directive 95/46/EC has provided the foundation for “the protection of individuals with regard to the processing of personal data and on the free movement of such data”.…
Read MoreThe Silliest Thing We Can Imagine
Elon Musk decided to test his revolutionary Falcon Heavy rocket with the “silliest thing we can imagine”. Usually test payloads for new rockets are made of boring hunks of steel and concrete, but if Elon’s past actions are any indication –see his Boring Company branded flamethrower— normal just wouldn’t do. So Musk tweeted out this…
Read MoreFear, Indecision, And The Memo To File
“Just write a memo to file.” How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself? A memo to file (MTF) is a document filed in the trial master file (TMF) that is intended to…
Read MoreThe 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…
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