Make That an "e" Please

If only it were that easy. "I'd like data collection, the common technical document, patient reported outcomes, oh...and could you make sure that's all e?" And we all know e means electronic. And electronic is just another way of saying software, which should be just another way of saying easy, but easy e is not at first. At a recent eCTD roundtable, Clarkston Consulting asked a group of regulatory experts who would be considered early adopters on the eCTD technology-adoption curve to share their eCTD implementation experiences. They also asked Applied Clinical Trials to join and to share those insights and experiences with our readers. The discussion was frank, and informative.

For most regulatory affairs professionals, there is a comfort level with paper submissions. It's familiar. And as many at the roundtable related, paper equals a level of control and satisfaction over the process. In fact, advice given by the experts for moving from paper CTD to eCTD was all about getting comfortable and letting go of control.

For upper management and executives, the advice ran more along the lines of emphasizing the returns on investment to help ease the pain of implementation. Those ROIs include:

* "Consistently quicker submissions"
* "Getting to marketing faster"
* "Submissions in hours instead of weeks"
* "Substantial reduction in the size of submission staff."

Another point brought out by the panel members was choosing your eCTD software vendor wisely. The topic of vendor selection has come up before in Applied Clinical Trials (even articles in this issue) and is a mainstay to our content because of the nature of our industry.

Every outsourced function in drug trials is selected—from the CRO, to the lab, to the investigative site, to the software and technology needed to tie all the pieces together into one coherent submission. Choosing wisely based on benchmarks, past performance, future projections, financial stability, and more fuels many a discussion.