Sponsors and CROs trying to achieve better enrollment in clinical trials often overlook the most essential stakeholder in the process — the investigative sites that implement the trials and interact with the patients throughout the process

Behavior Should Drive Clinical Trial Training, Not Test Scores Applying analytics that focus heavily on measuring changes to research staff behavior during training can be a strong predictor of performance during an active clinical trial, leading to better protocol...

As part of our series covering all the do's and don'ts surrounding protocols, I wanted to call attention to one of the greatest urban legends in clinical research...the requirement to include endless footnotes (in size 6 or 8 font no less!), at the end of the schedule...

Over the last several years, the pharma industry, along with the world at large, has become increasingly focused on issues of diversity. This has been reflected in regulatory guidelines, government and industry policies and in the clinical trial recruitment phase of...

Although it can be tricky to acquire proper clinical site training, inadequate planning for a research study's training needs will create unnecessary, avoidable costs down the road. Let's take a look at a not-so-uncommon scenario. You budgeted about $20 million...

At the outset of this post, I want to make one thing clear. I am a huge fan of and an advocate for CRAs.  I’ve been one and I have spent the better part of my career mentoring, teaching and helping CRAs develop their competency to effectively monitor clinical trials...

I have seen in my own life the power of nature vs. nurture.  I was adopted at birth and recently connected with six birth siblings.  It is interesting to observe both the power of nature and nurture.  We were raised in different homes and environments that helped...

PhRMA has adjusted its Code on Interactions, partly in response to the Special Fraud Alert issued by the OIG. Pro-ficiency is on a mission is to eliminate protocol deviations, one clinical study at a time. This mission is more important than ever, given the recent...

Are Your Sites Failing Your Training?  If Not, They Should Be!  Did you know that 100% of a seasoned clinical research audience attending a recent webinar all agreed on the key metric that should define investigative site training success?  Can you guess what that...

SAS CEO Jim Goodnight famously quoted “Ninety-five percent of my assets drive out the gate every evening. It's my job to maintain a work environment that keeps those people coming back every morning." (1)  But what did he mean by “assets”?   Financially speaking, an...