Over the last couple of years, it’s become increasingly common for clinical studies to draw on data gathered from EMRs — so common, in fact, that last year the FDA issued official guidance on how researchers should use such data.
Intermingling research observations and EMR-based clinical data poses different problems than provider-to-provider data exchanges. Specifically, the FDA recommends that when studies use EMR data in clinical investigations, researchers make sure that the source data are attributable, legible, contemporaneous, original and accurate, a formulation known as ALCOA by the feds.
It seems unlikely that most EMR data could meet the ALCOA standard at present. However, apparently the pharmas are working to solve this problem, according to a nice note I got from PR rep Jamie Adler-Palter of Bayleaf Communications.
For a number of reasons, clinical research has been somewhat paper-bound in the past. But that’s changing. In fact, a consortium of leading pharma companies known as TransCelerate Biopharma has been driving an initiative promoting “eSourcing,” the practice of using appropriate electronic sources of data for clinical trials.
eSourcing certainly sounds sensible, as it must speed up what has traditionally been the very long process of biopharma innovation. Also, I have to agree with my source that working with an electronic source beats paper any day (or as she notes, “paper does not have interactive features such as pop-up help.”) More importantly, I doubt pharmas will meet ALCOA objectives any other way.
According to Adler-Palter, thirteen companies have been launched to provide eSource solutions since 2014, including Clinical Research IO (presumably a Bayleaf client). I couldn’t find a neat and tidy list of these companies, as such solutions seem to overlap with other technologies. (But my sense is that this is a growing area for companies like Veeva, which offers cloud-based life science solutions.)
For its part CRIO, which has signed up 50 research sites in North America to date, offers some of the tools EMR users have come to expect. These include pre-configured templates which let researchers build in rules, alerts and calculations to prevent deviations from the standards they set.
CRIO also offers remote monitoring, allowing the monitor to view a research visit as soon as it’s finished and post virtual “sticky notes” for review by the research coordinator. Of course, remote monitoring is nothing new to readers, but my sense is that pharmas are just getting the hang of it, so this was interesting.
I’m not sure yet what the growth of this technology means for providers. But overall, anything that makes biopharma research more efficient is probably a net gain for patients, no?