Lisa Henderson
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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.
These were the panel's recommendations for choosing eCTD software and a vendor, many which can be applied to other software/technology
specialties: Do your homework, make sure the company has references, bring in a couple of vendors to evaluate (but not too
many), is the software flexible, and examine your needs and processes upfront first.
Is your software going to define your process or is your process going to define your software? To that question, the experts
agree that your process should come first; however, you may need your process reengineered, to which a business reengineering
consultant can provide outside advice on the best ways to achieve that.
As one panel member said, "If you have trouble in the paper world, you will have problems in eCTD."
We'd like to thank Clarkston Consulting for letting us be a fly on the eCTD wall. We're also extremely grateful to the professionals
who shared their experiences. Look for upcoming podcasts, online articles, and features based on eCTD here and at http://appliedclinicaltrialsonline.com/.
Lisa Henderson
Editor-in-Chief
email: lhenderson@advanstar.com
http://www.appliedclinicaltrialsonline.com/
