Is the contract research organization serious about owning technology? It’s not clear.

A peek at the eight regular members of ACRO, the blue-chip Association of Contract Research Organizations, reveals that just two companies own industrial strength electronic data capture (EDC) solutions. The rest are choosing to partner with technology firms—or remain shy and bashful about the contents of their technology arsenals.

Such is not the case with Jubilant Organosys. Yesterday the publicly traded Indian firm bought the web-based EDC solution from TrialStat. The price: a surprisingly low $611,000. Jubilant specializes in contract manufacturing, but it also owns a U.S. CRO, 400-employee Clinsys Clinical Research. The improbable result: A company based in Uttar Pradesh, India, now owns stronger, more modern EDC technology than most of the largest CROs in the industry. Go figure.

Tech, Service Mix

We’re hardly privy to the strategy at Jubilant. But it’s clear the firm believes (unlike the largest U.S. CROs) that software for clinical trials is something worthy of investment. “EDC is here to stay,” says David Williams, global CEO of Clinsys. “Big pharma has been pushing it. To get something of this magnitude is a phenomenal coup for us. I’m very, very pleased.” Most of the TrialStat employees will remain with Clinsys, he says.

In bidding on projects, Clinsys typically prepares two quotes, one with EDC, and one with paper data collection. The firm (with U.S. offices in Philadelphia and Bedminster, New Jersey) expects to win additional business with the TrialStat technology. “It will help us position ourselves against the other CROs,” Williams says. “We think it has a lot of value for us.”

Easy Interface

The interface of TrialStat’s EDC application was judged to be superlative, Williams said, meaning that it is significantly easier to use than what many sponsors have grown accustomed to. He predicts that alone will help the firm win projects.

And in contrast to CROs that have worried about the top-line impact of EDC technology that might result in reduced needs for other CRO services, Williams sees EDC helping to bring in more revenue. “We do want to be able to offer a quality, strong product to our sponsors at a very responsible price,” says Williams. “EDC is going to improve our top line dramatically.”

Nothing To Install

Without servers or special software, the completely web-based approach of TrialStat is what the industry will want in the years ahead, he predicted. “It’s the whole software as a service (SAAS) technology,” said Williams. “Rather than the application service provider (ASP) model, this is the way to go. It will be easy for us to develop services to put on to it.” The company has five main therapeutic areas (oncology, central nervous system, dermatology, respiratory and cardiovascular) and also has a division supporting functional service provider needs of sponsors. 

For all of its projects, Clinsys can offer an intensive project management effort called Global Project Solution. It will be interesting to see if the firm can extract additional efficiencies from EDC. Williams notes some companies in the industry have not necessarily updated their scheduling of site monitoring visits to capture the cost savings possible with EDC, preferring to preserve the approach of the pre-computer era. Says Williams: “You’re able to really look at the data when you plan making your site visit versus just looking at the calendar.”

He and his team were especially impressed that the TrialStat system will be cheap and flexible enough to use in both Phase I and post-approval registry projects. “It’s a leg ahead of everybody else,” he said of the TrialStat technology.

As with this summer’s acquisition of ClinPhone by Parexel, Clinsys will use the EDC technology internally and offer it to other CROs. Says Williams: “We are going to keep a Chinese wall up so that the CROs are not concerned about us being a CRO.”

Slower Sponsor Decisions?

TrialStat personnel will continue to work out of their office in Ottawa, Canada, though the help desk may be augmented to include additional coverage from India. “We can have a seamless interaction with our sponsors on a 24-hour day,” says Williams. “That doesn’t decrease any work being done in Canada.”

In general, Williams says, the troubles of the financial, real estate and auto industries have not yet affected clinical research. A few projects have been slightly delayed, but only for regulatory reasons. Williams candidly says he has no credentials as an economic prognosticator, but says that so far the number and scope of projects at Clinsys have not diminished.

“Caution is what we’re seeing more of,” he reports. “Our backlog is strong. We are seeing strong request for proposal (RFP) volumes and strong award volumes. I do think the decision-making process will slow down somewhat.”