There can be a slight chill between contract research organizations (CROs) and electronic data capture (EDC) firms that work together. In a pinch, either firm could dent the credibility of the other. It’s not always clear whether this CRO or that EDC firm might be included or omitted from a future bidding opportunity.

The partnership between INC Research and Medidata sounds different. Warmer, to be exact. There was a genuine friendliness on the line when we checked in with both companies recently. And there was enough of a hint of the speed bumps that pop up in any real relationship to make us surmise that this particular CRO-EDC partnership runs deeper than a press release.

One example. Contracting for the two firms seemed to be taking too much time. A task force to iron things out was formed. Problem solved. “The issue has gone away. It’s a non-issue,” says Alistair Macdonald, senior VP of data services at INC Research.

Unplugging OC

Macdonald says an impressive seventy percent of the trials now being booked at the CRO involve EDC. His firm, based in Raleigh, North Carolina, is moving away from the EDC product of Oracle Clinical, like most of the rest of the industry.

Transitioning to Medidata, Macdonald says, makes a new and larger group of trials appropriate for EDC. Which is good, because his firm (which targets trials in pediatrics, oncology and the central nervous system) is starting to run projects in metabolic and cardiovascular disease. The INC-Medidata relationship provides an interesting window into potentially rising expectations for EDC across the industry as CROs embrace the technology and make the trains run on time.

Not surprisingly, Macdonald finds the Medidata EDC system, called Rave, versatile. “With Rave, you can do just about any study,” he says. “We have not come across a study we couldn’t run in Rave.”

This isn’t a typical partnership with a technology firm, Macdonald says. “We came at the Medidata partnership in a different approach than we normally do,” he says. “We’ve been wide open to each other. There are no secrets. It is not a typical vendor-customer relationship. It’s a team. It sounds corny, but it’s the case.”

Same Language

We didn’t get all of the details. But part of INC’s approach to managing its clients seems to be to track eight key metrics—budget, scope, time lines, satisfaction and others. If any of them shift, in traffic-stoplight fashion, from green to orange, the company reacts immediately.

There’s a process to work out whether a deviation from the schedule is necessary, and escalation plans to rectify the situation with additional (or different) personnel. Macdonald notes that Medidata employees have been trained in that vernacular. Says Macdonald: “We don’t have to explain anything to Medidata when we say, ‘We need this by the fifth of the month.’ ” The need to change a time line is, to put it delicately, frowned upon.

INC’s fastidiousness around time is, it believes, appropriate given the stakes. “If we miss a database lock,” Macdonald says, “it’s been discussed with a customer for months. The biggest database lock delay we have had in years was a week. That was because of third-party lab data we couldn’t get out of a large company.”

Army Ethos

How the does the CRO stay on track? “We don’t wait for things to go bad,” Macdonald says. Translation: It’s not permissible to blame your issue on some other person in some other organization. “We see the early indicator, we get on the phone, and we hit the time line. The CEO’s favorite statement is ‘failure is not an option.’ He’s an ex-military guy and he makes it very clear.” (That would be a reference to INC’s James Ogle.)

Macdonald elaborates: “Pharma companies rely on us to make time lines that they couldn’t make. With EDC, there is the added factor that whenever that first patient visit occurs, the study has to be ready to roll. We strive to hit every deadline. We strive to do it better than any pharma company could think about doing it.”

Face To Face

As he talks, it’s clear the CRO, in its hiring, seeks a balance between people who are polite enough to work in a large organization—and sufficiently brassy to make sure no project veers off schedule. Not everyone survives in that environment, Macdonald concedes, but one of his biostatisticians has been at INC for 13 years.

Some of the conversations between the EDC vendor and CRO, of course, can be tense. So the INC-Medidata relationship has built-in, face-to-face meetings early in every project. “It’s much easier to work and communicate with someone you’ve met face to face,” says Macdonald. “That helps to grease the wheels so that when the bad times come, I’m not picking up the phone to talk to someone I’ve never met.”

Deep Training

Communication is emphasized. “As soon as we know something is going to change, we tell Medidata. If they know something they tell us,” says Macdonald. “We’ve had cross words on the telephone and face to face. If I can’t call Graham and say, ‘You’re screwing this up….’ ” At which point he laughed.

“Graham” would be Graham Bunn, VP of global CRO partnerships at Medidata. He notes INC Research personnel have received the same exhaustive study-build training that all of Medidata’s own employees undergo, with more than a dozen INC staffers having completed the process. The seriousness and thoroughness of the training, certification and testing on the Medidata EDC platform set the relationship apart, he says.

Non-Compete Clause

Bunn says the software firm has tweaked its sales incentives to make sure that cooperation with CROs, including INC, truly occurs. Bunn is firm on the point: “An open partnership is one where we do not compete. That’s there and on the line.” Both companies maintain their sales teams honestly and enthusiastically pitch the other party’s solutions to clients.

Referring to an earlier position in which he worked at a large CRO, Bunn says that approach is new. He acknowledges the Alice-In-Wonderland language that can be tossed around in relationships between EDC firms and CROs. “I was often competing with an EDC vendor that was claiming to be my partner at the same time,” he says with a chuckle.

Despite his current roost at a technology firm, Bunn says it’s clear to his colleagues at Medidata that time lines in the CRO industry are strict. “The pressure is a lot more,” says Bunn. “The cost of missing one time line is in the tens of millions.”

PostApproval Boom?

But the synergies are equally sizable, with each firm being able to handle what it does best. “The two organizations get on very well,” says Bunn. “The cultures are very similar.”

Bunn adds that there have already been early dividends as Medidata and INC have become more familiar with each other’s tools. “Certainly Phase IV is something we’ve seen growing in the last quarter, particularly in the registry process,” he says. “We’re seeing people looking for faster build processes. They can get that EDC study from project hold to completion much more quickly.”

As more studies across the industry use EDC, other CRO and EDC firms may face pressure to find their own shared efficiencies, hammer out their own corporate synergies. It will be interesting to see whether the closeness of the INC-Medidata alliance can be duplicated—whether other CRO-EDC partnerships will be able to sync up their core skills, human assets and communication channels in a similar way.