87 Questions To Consider: A Must-Read Guide To Assessing Key Areas of a DIY EDC Option for Your Company

October 24, 2014
Marylyn Donahue

Applied Clinical Trials

What's been a commonplace technology for larger organizations is now becoming more accessible economically to smaller enterprises. But how to choose?

Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.

Until relatively recently, taking your company's clinical research into the realm of electronic data capture (EDC) meant going with a full service vendor with a price tag generally starting at $175,000 to $200,000 for a 250 patient, 50 site trial over 24 to 36 months, and as high as your project was complex. If you wanted to conduct smaller scale research, these were often just not economically feasible—the same pricing as just mentioned might be provided for a 50 patient, five-site trial.

Why not "do it yourself" (DIY), then? Certainly it is an available option to decrease costs from some of the larger EDC companies, but often only less expensive if you are doing large volumes of research and can afford to have skilled "build" specialists trained and on staff.

Again, the net result is that smaller companies either remain in a paper world with all its attendant woes, or are compelled by cost-containment needs to select markedly sub-par EDC systems almost as problematic as the old paper model.

Over the past three to four years, however, viable DIY EDC options have begun to emerge onto the marketplace that make what has become a commonplace technology in larger organizations more accessible economically to smaller enterprise.

As every weekend warrior tackling an at-home project knows, you may be doing it yourself, but you still need expert guidance. This is a thousand times truer when it comes to finding, assessing, and selecting DIY EDC. And it is by no means as simple as it might at first appear.

Timothy Pratt, PhD, in this peer-reviewed article that first appeared in Applied Clinical Trials (February 2013), has both lived through the process for himself and also recently tested it for a small medical device company. He takes you through each step along the way, which turns out to be not unlike a beauty contest— a process of elimination.

Except in this contest there's a rigorous first step—finding the contestants. It is a relatively new field. As his most useful resource, he cites the Applied Clinical Trials' Annual Buyer's Guide.

With each step, Pratt supplies both what you need to look for and also what you need to look out for—the pitfalls—and what questions to ask to avoid them. This standardization assessment process that includes systematic scoring of vendors and their offerings, Pratt sees this as critical to the selection process whether it be in the areas of pricing or performance.

"Finding and assessing an electronic data capture methodology is a task that must be approached methodically in a structured manner," says Pratt.  "EDC systems vary so much in capabilities that the only valid way to make good judgments on suitability is via standardization of the method of assessment. This is especially true for the smaller life sciences company that may not have the in-house expertise to rely upon, and seeking CRO or consultant help may be invaluable. Enabling cross-vendor pricing comparisons through use of models can reveal critically important information on product scalability and economic feasibility for different project types. Finally, careful consideration of your company's specific needs may lead to weighting of particular components or dimensions of DIY systems which can help differentiate vendors when a clear 'winner' is not present."