From EDC Emerges eClinical

Last month, Health Industry Insights released its eClinical Buyer's Guide, Part 1, Electronic Data Capture, focusing on the EDC vendor landscape. As Alan S. Louie, PhD, and author of the report told Applied Clinical Trials, EDC is becoming a mature technology. Couple this with CDISC standards within vendor's products, which provides easier interoperability, and the EDC market actually is "less competitive."

The eClinical Landscape

What does this mean for EDC vendors and the biopharma companies that buy their software products? For vendors, Louie predicts further consolidation of them by other EDC vendors and by CROs. The report highlights the M&A activity that occurred in this space in 2008, including Parexel's purchase of ClinPhone, BioImaging's acquisition of Phoenix Data Systems (now known as BioClinica), and Medidata's purchase of Fast Track.

More recently, in June and July of this year respectively, were OmniComm System's purchase of ERT's EDC product suite, and Covance's selling of its IVRS/IWRS services to Phase Forward.

Steve Johnson, COO of OmniComm Systems, agreed with Louie's consolidation prediction. He called OmniComm's purchase of ERT's EDC suite a move to grow its business to compete with the tier one players, those making over $100 million in revenues, which are Phase Forward and Medidata.

Johnson explains that the acquisition allowed it to assume a competitor, as well as expand its offerings to customers as a plug and play suite. OmniComm is currently in talks with two other acquisition targets that will round out its line, and is open to similar opportunities.

OmniComm's current profile models what Louie sees for the near future for EDC vendors: future consolidations that focus on acquisitions of products that complete a company's offerings to a full eClinical suite. Or further consolidations of EDC/eClinical companies that allow market penetration in specific areas, for example, academic medical centers, smaller pharma, medical device sponsors or in a particular country.

To be sure, these modules or capabilities that vendors offer to round out their offerings are the larger movement that is eClinical. And that is the future that buyers need to be aware of. As Louie explained, EDC is not sold as a separate offering. "EDC vendors automatically bundle in a CTMS (clinical trial management system) or have a repository built in," said Louie. The hope being that a bundled or comprehensive software product will continue to be used by the client (sponsor) rather than seeking out different products to plug into the system. Other eClinical capabilities can include CDMS (clinical data management systems), drug safety/pharmacovigilance, clinical trial design, ePRO, thesaurus management, IVRS/IWRS, FDA submissions, and CRO management.

It is the Web that brought EDC to maturity and is bringing the rest of the companies into eClinical. As Johnson explained, "It is the improved security and the performance of the Internet in the past couple years that explains why EDC has taken off."

The major benefits of Web-based solutions according to Louie are: "You don't have to manage the software on the site." And because of the large, multicenter trials, "the Web-based solutions also serve the distributed trials or global trial data needs."

As part of its recognition that EDC is no longer the end goal, but eClinical is, Health Industry Insights will present additional reports in its eClinical Buyer's Guide series in the coming months. Louie anticipates that drug safety will be next.

Market Analysis: The Health Industry Insights eClinical Buyer's Guide, Part 1, Electronic Data Capture is available for purchase from IDC/Health Industry Insights at www.idc.com.—Lisa Henderson