As the industry enters a period of eClinical consolidation — ClinPhone and Datalabs, PharmaLinkFHI and Matrix Contract Research, Parexel and Green Mountain Logic — and as the adoption of these technologies swells, not only has the playing field narrowed for these companies, but the game itself is changing.
The topics of metrics, analytical tools, integration and standardization were some of the most discussed eClinical trends during the Drug Information Associations (DIA)'s 44th Annual Meeting in Boston.
Needless to say, these issues have not been lost on eClinical vendors.
According to many in the industry, it is no longer the adoption of technology that the industry is calling out for now, those numbers have risen considerably, but the need for a change in the way clients use eClinical tools within their organizations. There may be less fragmentation in the eClinical marketplace, but CROs and sponsors are looking to get much more from the technology being offered.
CenterWatch had a chance to sit down with executives from New York, N.Y.-based eClinical provider Medidata Solutions’ Glen de Vries, co-founder and president and Ed Seguine, general manager of trial planning solutions and former chief executive officer of Fast Track Systems. Seguine joined Medidata when Fast Track was acquired in March 2008.
“What’s so interesting about the eClinical industry, is that the clinical space is so desperate for change from a business process perspective that you have difference forces now, that you might not ordinarily have in a maturing technology market,” said de Vries, who has also been the Medidata’s chief technology officer since 1999.
Medidata is giving its CROs the option to make the most of its product by joining a – non-exclusive – partnering program that requires accreditation, individual employee certification, review systems and considerable knowledge transfer.
It is a huge leap of faith for both vendor and client, but according to Medidata it will ensure that sponsors are getting the kind of results they need from their CRO.
“It doesn’t do anybody in the industry any good to be deploying poorly designed studies, and certainly not with our product. A sponsor might look at that study and say: ‘maybe Rave didn’t work’. At the end of the day you want the products reputation maintained, so that is why it is necessary that a certain minimum threshold be established. It is a joint commitment among both parties,” said Seguine.
Raleigh, N.C.-based contract research organization PRA signed on to ASPire to Win program in June, becoming the 11th CRO to join. PRA had been using Medidata informally since 2000, but chose to enter the program because it wanted to integrate “Rave-related EDC services” to its own the electronic data capture (EDC) systems. Many of Medidata’s other CRO partners have echoed that desire as well. CROs that are looking to combine a pre-existing EDC platform with a new clinical data management system (CDMS), or vice-versa, need a lot of help from such a vendor. PRA stated it has already conduct 150 trials using EDC technology across the world and that number can only go up from there.
“In the beginning of these relationships, we may be providing a lot of consulting services to CROs, sharing best practices or even backfilling some of the things they haven’t learned how to do or haven’t gotten certified yet. And over time, they learn more and more,” said de Vries.
Other eClinical companies have been attacking the issue of technology integration as well; however, Medidata’s CRO partnering model seems to be highly successful giving the amount of clients they have stacked up already.
ASPire to Win isn’t the only way the company is attacking the integration need. Medidata recently launched its web Services application programming interface (API) to make quick work of the process of integrating different technology systems with Rave
“Our trial planning team is fully integrated into the company since the Fast Track acquisition has been occurred three months ago. We actually demo during the [DIA] show how you can be in Designer, our protocol design product, and log straight into Rave. So, from one product to the other, without human intervention. So you can have a new trial or revisions to an existing trial available to you instantaneously. More importantly, the tools that we did to do that are the same tools that we are now providing to technology partners through the web API service,” said de Vries.