At LMK, we believe that our dedicated team is the key to our success. This month we interviewed Jackie Morrill, our Executive Director of Clinical Operations, who has been with the team for 4 years. Jackie tells us what she enjoys about her key role at LMK, her most memorable project, and what her go-to…

Part 3: 21 CFR Part 11 As part of a recent webinar series, LMK Clinical Research Consulting was lucky 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…

Visit LMK at the 9th Annual TMF Summit Now that the holiday season is over, the TMF experts at LMK are refreshed, reenergized, and ready to help you tackle your most pressing TMF challenges in 2020. As part of our mission to ensure TMF success for all, we’ll be attending the 9th annual Trial Master…

Like so many tangled strands of holiday lights, making sense of an unhealthy TMF can bring out the opposite of holiday spirit. Still, LMK’s TMF experts have been working all year on the most challenging TMF problems. They have found obstacles that may at first seem impassable can be overcome when the right technology and…

Part 2: MHRA Gray Guide 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…

At home with our family and friends and surrounded by delicious food and drink it is easy to count one’s blessings. The benefits of gratitude, however, are available all year long and extend far beyond the border of the Thanksgiving table. LMK’s TMF experts have even found that gratitude, a quality of open appreciation for…

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…

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…

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…