EDC users still rely heavily on paper

Electronic data capture (EDC) is great for recording structured information like a lab test result, but the technology hasn't been great for capturing all the unstructured notes and other scribbles that go into a patient record during a visit with a doctor. There's also a lack of standards for making EDC interoperable with electronic health records (EHRs), furthering the impracticality of the technology at the point of care.

Yet there has been some progress in providing doctors with a way to gather data from patients electronically directly from patients for clinical studies--without requiring investigators to create paper documentation. In an interview with eCliniqua, Clinical Ink president Edward Seguine talked about how his firm's electronic source document system SureSource can help cut some of the paper-based documentation headaches and costs out of clinical research. (Seguine sold his previous company Fast Track, a clinical trials planning software and services provider, to New York-based EDC vendor Medidata Solutions ($MDSO) in March 2008).

When I briefly met Seguine last month at the Bio-IT World Conference & Expo in Boston, he showed me how Clinical Ink's software functions on a tablet computer to create electronic documents for clinical studies. He showed me how the system could record comments (which might fall into the "unstructured" category) as well as structured information associated with showing whether experimental products meet goals in clinical studies. He reminded me that EDC requires sites to create a lot of paper-based documents--documents that his firm's software generates electronically.

Still, Winston-Salem, NC-based Clinical Ink is an emerging player and EDC is nowhere near being displaced by the upstart's technology. However, there could be increased demand for the small firm's technology, especially as trial sites try to reduce the burden of creating and managing paper documents for clinical studies. And if the technology works as well as Seguine says, I could even see a big EDC vendor coming along and acquiring Clinical Ink at some point to differentiate its clinical trials offerings.

- read more in the eCliniqua article
- here's Clinical Ink's website

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