IT Expert: Top Pharma Firms Use EDC for Clinical Trials

The world’s top 20 pharmaceutical companies are completing their transition from paper case report forms to electronic data capture (EDC) systems for clinical trials, according to an industry leader.

EDC is still a growth industry, but the growth is likely to slow in the next three to five years, Nick Giannasi, senior director of Oracle’s Health Sciences Global Business Unit, said.

“One of our clients, a top five pharma with headquarters in Europe, now does 20 percent of its trials on paper and wants to move to all EDC trials within three years,” he said.

“A lot of studies are still run on paper, so I think the EDC market will continue to grow for a number of years and then plateau,” he continued. “Although it will vary slightly in different regions of the world, we expect growth to slow down in the next three to four years and plateau in three to five years.”

One challenge Giannasi cited is “true scalability” of EDC systems so they can easily accommodate additional users. This problem has to be solved on both the front end — the part the user sees on a computer screen — and the back end that programmers are familiar with.

Another problem for EDC systems is that sponsors frequently require investigators and sites to use mutually incompatible systems. Giannasi said this problem affects Oracle and fellow industry leaders Phase Forward and Medidata. “Investigators are getting fed up with having to maintain different systems, so there will be consolidations,” he predicted.