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.
Of course, the option has been available from some of the larger EDC companies to "do it yourself" (DIY) in an attempt to
decrease costs, but these were often only less expensive if you were doing large volumes of research and could afford to have
skilled "build" specialists trained and on staff. The net result is that smaller companies either remained in a paper world
with all its attendant woes, or were compelled by cost-containment needs to select markedly sub-par EDC systems almost as
problematic as the old paper model.
Of late however, perhaps over the past three to four years, 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.
Finding, assessing, and selecting DIY EDC though, is an activity that is by no means as simple as it might at first appear.
Having lived through this exact process very recently, this article seeks to share experiences in the hope they may prove
useful to others in similar positions.
The company for whom I was evaluating systems, a small venture capital backed medical device company, had previously conducted
a number of studies on paper using as a backend a well-known and relatively inexpensive CDMS. The largest and most recent
of the studies conducted required a considerable amount of data cleaning after the enrollment period closed—largely because
data errors had been introduced due to the nature of a dynamic non-point-of-capture-checked data acquisition. The burden placed
on the company in cleaning up this rather complex trial dataset was very significant, and contributed in no small part to
the decision to investigate DIY EDC systems.
Given the upcoming projects, which varied from moderate to quite small in nature, full-service EDC was not seen to be a viable
option. I was requested, given my background in EDC/CTMS system design and implementation, to source, evaluate, and recommend
a DIY option. Cost was not a primary consideration, but neither was it immaterial, as one might expect in a small organization.
With years of experience and more than a few systems under my belt, I foresaw little difficulty in conducting this project—get
a few demos, jot down a few notes, make a recommendation, and sign contracts. Much to my surprise and chagrin, my assumptions
were proved wrong almost immediately.