EDC Technology for Clinical Research – A Primer
By Kathryn VanOsdol, MHI, BSN, RN & Mike McKenzie, MHA
So, your organization is preparing to launch a clinical study? Like many companies, you have evaluated potential contract research organizations (CRO’s) for qualities such as experience, customer satisfaction, and quality assurance. A decision maker in your sphere of influence recommends a CRO with a technology solution that will expedite deployment of the study. You think, “Great, problem solved!”
As you've probably heard it said in the movies – “Not so fast my friend!” Each day of delay to bring a product to the market results in an average of $300,000 of lost revenue. Moreover, this technology is going to be the face of your company to physician and patient participants. In light of these dynamics, it’s important to consider several key factors that are often overlooked when evaluating a technology solution.
The first key factor is usability of the solution. The best stadiums in the world won't attract a crowd if the fans can’t find their way from the parking lot to their seats. The same can be said for your technology. Clinicians need an easy to use, functional and secure application for the entry of clinical data. Let’s be real; physicians have reported the number one contributor to burnout is dissatisfaction with electronic health records (EHR’s). Athenahealth, eClinicalWorks, Epic, Cerner, CPSI and the like have collectively spent BILLIONS trying to improve usability and promote user adoption. It’s worth asking the question of the CRO turned would-be EHR expert: “What makes this user interface more desirable than the current EHR experience?”
“Walk a mile in their shoes”; the statement has meaning when implementing a clinician-facing platform for robust data collection. Assembling a team that is experienced in healthcare technology and clinical documentation workflows is critical. I cannot stress this enough, so I'll say it again- critical! The health system industry has over 90% adoption rate of EHR’s; the ideal technology partner should have knowledge of existing documentation systems and how to capitalize on things like EHR reporting and interfaces to expedite data collection.
“Service with a smile” has become part of the world’s vernacular. Companies like Amazon have set the service standard; it’s expected that issues can and do arise that will require competent assistance. This is especially true with clinical technology. In a world where health system stakeholders have repeatedly been disappointed by technology vendors, this is an opportunity for your organization to shine. Having a technology partner capable of fielding, troubleshooting and correcting problems will be critical to the success and speed by which you capture data.
To recap important technology selection criteria for your clinical study; keep in mind these quotes:
- “Not so fast my friend” – verify the data collection technology is user-friendly.
- “Walk a mile in their shoes” – ensure the technology vendor understands EHR’s and workflows.
- “Service with a smile” – evaluate their track record with service delivery.
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CRO48 is a Clinical Research Organization created by physicians, clinical informaticists, and health information technologists to provide technology that is innovative, easy to use, and secure.