The contract research organization (CRO) has never been swayed by gimmicks or buzzwords about technological miracles. Hitting the timelines on complex trials, year after year, is not easy. The Darwinian rigors of survival in such a demanding environment have bestowed a conservative and cautious temperament on the CRO industry. Appropriately so.

Now the CRO industry is not just using electronic data capture in a grudging manner, but making the technology its own. Quintiles is boasting of having done hundreds of trials using EDC.

The shift is still too fresh to gauge with quantifiable metrics or facts (not that any reliable statistics are gathered by a publicity-averse industry). The CRO industry is recognizing that EDC has matured. It is not going away. And as CROs relax their earlier skepticism of EDC vendor claims, they can contemplate actual enthusiasm for the technology and explore how it can fit into their existing processes. Old wariness is beginning to dissolve.

A Tectonic Shift

Indeed, CROs are seeing EDC differently—and not just because more sponsors are requiring them to use it. CROs are finding their own reasons to use EDC, slowly coming to an understanding of their own rationale for the technology. There is less concern that a stumble by an EDC organization will bruise a sacrosanct relationship with a sponsor. Or that busy, prosperous EDC vendors will use access to the sponsor to provide services that the CRO would prefer to handle itself.

There are changes afoot in the technology space as well. For years, EDC suppliers quietly complained that the CRO industry seemed more interested in maintaining head counts or top-line revenues than achieving efficiency or clean data. Now the tune is different. Some vendors see CROs as crucial extensions of their own trial build and implementation teams. There is less grumbling that some CROs might be snipping their technology partners out of the bidding loop, or adding excessive margins to bids that EDC vendors had wanted to present conservatively.

Détente Arrives

CROs and EDC firms are cementing increasingly formal ties, beefing up the training, and learning to cross-sell the products and services of each type of organization. Sensitive information about cost and staffing is being shared across the CRO-EDC divide. In the healthiest CRO-EDC partnerships, the goal is to let a services organization do what it does best, and let a technology organization do what it does best. Behind the scenes, candid communication and rapid troubleshooting must be raised to a new level for a myriad of reasons that boil down to getting the job done on time, at something close to the quoted price.

The crux of the matter, frankly, is that some clinical service and technology organizations understand they will be obliged to cooperate to support rising numbers of EDC-based studies all over the planet this year and in the future. In theory, there should be enough work for many CROs and EDC firms to a) use EDC and b) prosper. If there are efficiencies to be had in the bargain, splendid. But of late one hears less about the marvels of EDC—and more about managing EDC projects with strict respect for the schedule. It’s not just about the technology in 2008. EDC is evolving into a service like any other.

If You Think About It, Editorial Quality Assurance Is Your Job

In this website’s first in-depth report, harkening back to a dimly remembered career as a print journalist, we’ll assess where the CRO and EDC industries stand and how the nature of EDC will be changed as a far larger industry embraces it. The second article concerns the strategies of EDC firms. Our third article has IDC analyst Chris Connor’s assessment of the historical roots of EDC-CRO alliances.  The fourth, outlining Kendle’s assessment of EDC, is here.