EDC: Advice for Current Issues

Applied Clinical Trials

Lisa Henderson discusses industry's advice on handling the potentially trial altering occurrence of EDC vendor merges.

Applied Clinical Trials has previously published opinion articles on what to do when your EDC vendor fails, as well as EDC rescue studies. Upcoming in August, we feature another article related to EDC rescue studies.

With the likelihood that your EDC vendor is going to merge with another company, what do experts suggest?

Alan S. Louie, PhD, and author of the latest Health Industry Insights report titled “eClinical Buyer’s Guide, Part 1, Electronic Data Capture,” which focuses on the EDC vendor landscape and says that consolidation within this segment will continue, recommends that any EDC buyer ask a vendor for a capabilities description as part of the RFP, especially in regard to its competitors.

Our own previous article, Common Ground for eCTD, suggests that a buyer also take a good look at the vendor’s financial stability.

For the consolidated company or merger situation, Steve Johnson, COO of OmniComm Systems-which acquired ERT’s EDC products in June-told Applied Clinical Trials that a concerted effort was key. Both OmniComm and ERT made sure the customer was first in mind and that they experience no disruption of technology. “We will continue to support the [ERT] technology. We do plan on taking the best of both product suites and developing a hybrid solution of next generation technology. And the customers will have the option to upgrade to that,” said Johnson.

But as far as rescue studies go, Louie says many vendors offer rescue-specific capabilities. “They are a little more high-touch and help the [sponsor] regain their confidence in the eClinical. Some large vendors can do that, and there are a number of smaller vendors who can do it also.” Louie adds, “There are concerns that having their vendors fail, they’ll have to spend more for integration.”

“Rescue trials are the last thing you want to do,” Johnson elaborated. “We’ve been involved in rescue studies; brought in when someone hasn’t been happy with their EDC vendor. We can do it. But it’s not easy.”