As contract research organizations (CRO) struggle to launch not just more trials but more complex studies, tension is built-in. A sponsor may ask that the CRO use a particular electronic data capture (EDC) supplier. But the sheer profusion of EDC vendors obligates some CROs to learn more than one system.

Therein lies the rub. It’s as if every document and spreadsheet in the world were created not using Microsoft Word and Excel, but with hundreds of unique, custom-generated software programs. In the field, in practice, using so many systems in the pharmaceutical industry threatens to overwhelm CROs and sites, potentially minimizing the efficiencies that technology was supposed to deliver in the first place.

This is territory that Chris Connor knows well. Senior research analyst, clinical development, at Health Industry Insights, an IDC company, he’s studied all three sides of the triangle—CROs, sponsors, vendors. And (just briefly) the globe-trotting uber-consultant is at a loss for words to describe a Faulknerian tangle of rivalry and reconciliation, competition and cooperation. Then the words spill out.

Once Upon A Time

Connor relates that he’s been watching the HBO television series on early U.S. president John Adams, and likens the industry dynamics at the moment to those between Britain, France, and the U.S. colonies in the late 1700s. In the end, he says, there will be peace, harmony and champagne. Eventually. But in the life sciences, until then, there may be some testing of boundaries and organizational mettle.

“The CRO industry was built on billable time,” Connor begins. “Their models were all top-line driven. Because everything was billed to time, efficiency wasn’t a necessary part of the business model. In fact, the more inefficient you were, the higher the top line was. There were in some instances incentives to be inefficient.”

On top of that dynamic, he says, the sponsor community’s relentless desire to lower costs and alter trials in midstream added a potentially dysfunctional element to the mix. Change orders were at the heart of a) sponsors’ needs to refine a trial and b) many CROs’ ability to earn back budgetary concessions surrendered during the contracting process.

Finding Balance

“In the negotiations, the sponsor had all the leverage and would negotiate contracts that were, in a lot of cases, unsustainable,” says Connor. Later, power shifted back to CROs as trials came to a close. “They could come in waves and waves and waves,” he says of change orders. “All the money the CRO should have made in the original negotiation was made then,” in the billing for the change orders.

Fortunately, Connor says, both sponsors and CROs began to realize there were fixable aspects to the situation. As a result, at least in the healthiest CRO and sponsor relationships, there has been a certain maturity and evolution toward less punitive negotiations (in the contracting phase) and more moderate billing for change orders (in the study closeout). A détente, an accommodation, had been forged. Says Connor: “Some kind of equilibrium started to develop.”

Trickle Down

Enter the technology vendors. The EDC firms tantalized the sponsor community with eye-catching cost savings. Trouble was, the profitability of the CRO engagements was already narrowly balanced. Slimming budget items for data management, or site monitoring, from trials (as EDC vendors advised) could potentially disrupt the CRO-sponsor detente that had been delicately won.

In some cases, there was an implicit or explicit expectation from sponors that CROs should absorb the hypothetical savings from EDC. “The EDC vendors got the sponsors to drink the Kool-Aid,” says Connor. “They sold the sponsors on efficiency and faster database lock and quicker time to market. The sponsors turned around and demanded that of the CRO industry. It essentially came in, ‘you’re going to use EDC, which is 20 percent more efficient, so we’re going to pay you 20 percent less.’ ” Is it any surprise the CRO community was less than warm about EDC in the early years?

The Battle Is Joined

Fast forward a bit. The EDC vendors had an Achilles heel, Connor says. They had designed their products to appeal most to data managers and biostatisticians. This was appropriate and wise at one stage, but eventually EDC began to impact a wider circle of clinical trial professionals. EDC companies came to see they needed the operational skills of other professionals to pull off their own obligations to sponsors, and, irony of irony, found the best folks in the world to solve those problems were employed … by CROs. Which were still wincing.

In essence, Connor says, CROs were being required to use EDC, to take a contractual hit, and team up with the very firms who had threatened to disrupt the hard-won equilibrium. “Now the gloves are off,” he says. “You really have a wholesale conflict. EDC is disrupting the whole CRO industry. They have to absorb it and are making less money.”

Time passed. Eventually, Connor says, EDC vendors and CROs began to work out more satisfactory arrangements, just as sponsors and CROs had. He likes CRO-partnering programs, especially the multi-level one from Medidata, and believes such efforts are beginning to address some of the lingering tensions in the EDC-CRO equation. Such programs, Connor says, may be able to align the needs and interests of CROs and EDC vendors.

A Silver Bullet

He’s also optimistic that data standards could provide a vendor-neutral way for CROs to should the burden of sponsors requiring umpteen different EDC systems. The CDASH effort, which we wrote about here, is a particularly promising effort to have more reusable ways to design the data structure (but not the appearance) of case report forms (CRF). Says Connor: “It starts to eliminate a basic problem for the CRO and sponsor, which is that every CRF is a one-off.”

How does the saga end? With more complex CRO-EDC relationships that are tailored to the individual strengths of the organizations in question. “What the industry wants is the ability to connect at various points in the value chain. It’s not one size fits all. That’s why there are so many CROs. The industry wants sustainable, multiple points of connection.”

Happily Ever After?

Connor says that both CROs and EDC firms understand that they need to work together in ways that are operationally close and financially rewarding. “The wariness is not gone,” he says. “It’s now a happy spirit of co-opetition. Each party knows how they have been burned before, and are aware how not to make those mistakes again.”

Likewise, Connor says the CRO industry is just starting to reassess the EDC universe and warm up a bit. “CROs were the most injured by EDC, and today they have to gain from EDC,” says Connor. “They need EDC. They need to be efficient. It’s not about billable hours. It’s about efficiently conducting these clinical trials. CROs need EDC more than anybody.”

Editor’s note: This article is the third in a series. The first installment, an overview of the EDC-CRO landscape, can be found here. The second article, on vendor strategies, is here. The fourth, outlining Kendle’s assessment of EDC, is here.