Technology in Clinical Trials

As I am getting older (and wiser?), I like to find ways to help myself and others do their jobs better – enter technology. 

Technological improvements are everywhere in our industry. Quite literally the industry wouldn’t grow without new tech. The most obvious improvements are the technologies related to making compounds and platforms that are the assets that we study. But outside the laboratory or clinic there are some more mundane technological advances that impact our daily activities. 

A pair of historic examples of how technology has changed the world for medical writers.  

• First, through a wider lens, is the advent of electronic case report forms. Remember paper CRFs? Volumes of paper, scans, faxes, smudges, and rooms full of data entry personnel digitalizing clinical trial data. Seems almost ridiculous these days, but I assure you this was real and really important. Shifting to eCRFs alleviated a huge bottleneck of data acquisition. While imperfections remain, this shift was an enormous jump into modern times. It changed how a wide cross section of people in clinical development worked. For medical writers it made the flow of information faster and more reliable.

• Similarly, and perhaps closer to home, is the shift from a paper submission (IND or NDA/BLA) to the eCTD and the integrated submission. The ability to cross reference another digital entity is a huge time saver and convenience to reviewers, but also to us as document developers. Knowing that we will have these materials available a click away changes the way we write and refer to items. We can be “leaner” knowing the source materials are easily accessible. 

But these are big picture items and while there may be another leap coming, I wanted to remind writers and editors that technology is our friend and can be hugely beneficial to our increased efficiency and accuracy.  

My advice to medical writers is to be flexible and try to adopt any bit of technology that can help you in your day-to-day or hour-to-hour work. Working smarter and embracing what technological advantages are available to you will help you do more and (hopefully) stress less. 

Michael Claffey

Chief Operating Officer