We’ve always envied tabloid reporters who can cover the surgery on “Siamese” or conjoined twins. Here at ClinPage, we seldom have the opportunity to write about anything with such drama. Where the stakes are fairly high. Until now.

In truth, this article concerns adolescents, not infants. For there are certain teenage Siamese clinical trial technologies that were surgically separated at birth.

Now those very technologies are being wheeled back into vendor operating rooms for what is said to be a relatively painless procedure to rejoin them. Welcome to software development for the pharmaceutical industry.

Siamese Surgery

Clinical trial technology companies seem on the fence about whether the word “integration” is appropriate. They prefer “combine” or variations on that term. Our sense is that the word “integration” is not yet an expletive, but that it may be viewed with skepticism after “integration” projects that, well, got messy.

Whatever the term, whatever the history, the need to deliver integration, i.e. combine complex types of clinical trial data, is only growing. A while back, ClinPage spoke to PharmaPros about exactly this topic. In a few days, we’ll have a story about Almac‘s efforts in the space. Today’s focus is ClinPhone. Both firms are making announcements to coincide with the European DIA event in Spain this week.

80 EDC/IVR Projects

In a perfect world, systems to randomize patients and the systems to gather data might never have matured separately. But they did. That’s what sponsors wanted.

Now Almac and ClinPhone are recognizing (as Clarix, DataTrak, and etrials have) that more seamlessness, easier unification of electronic data capture (EDC) and interactive voice response (IVR), would be a good thing.

“We’ve done 160 of those types of integrations,” notes ClinPhone’s Bill Byrom, VP of product strategy and marketing. Half of those projects have united EDC and IVR; half are combinations of other types of technology. Byrom has been with the firm since 2000. “Now what we’re looking at,” Byrom says, “is how can we take that knowledge to another level?” The strategy depends on using the company’s ”Connect” offering.

Enter Data Once

For a host of reasons, ClinPhone feels it would be ideal to have data entered once—just once—and populate other systems. “It’s the reduction in the duplication of effort that is the main benefit for the end user,” says Byrom. “You’re doing something once in one place. You’re not having to repeat that activity in a second system. It’s a huge efficiency gain.”

Managing the situation of multiple technologies should also get simpler. “There are examples where working with different vendors and solutions when the timelines you’re working on with one solution, such as IVR, are incompatible with another solution, like EDC,” says Byrom. “We can ensure those are smoothly synchronized.”

The customary phrase for having fewer suppliers to manage is called having “one throat to choke.” And in general, the unique approach taken by many life sciences companies is to have a dozen throats to choke. But we digress.

Adaptive Angle

The combination of EDC and IVR will generate new types of reports or reports that were harder to assemble in the past. “You can get an estimate of how long it is taking sites, the lag time, in terms of getting data into the system,” says Byrom. “It may flag one or two sites that are struggling to do the data entry. It could be they don’t physically have the resources to do it. It’s an early alarm bell for the sponsor to diagnose those problems.”

Properly united EDC and IVR, he says, will be crucial to making pre-planned operational course corrections in the middle of trials, the so-called adaptive approach. “The combination is really very important for an adaptive trial,” says Byrom. “What an adaptive trial relies on is quality data.”

But the most alluring aspect for sponsors may be combining EDC, IVR and a third type of system (for managing drug supplies). This can be thought of, in layman terms, as surgery that rejoins Siamese triplets. You may want to glance at the textbooks before trying that at home.

Experts Only, Please

But such procedures are at the heart of the appeal for combining more than one technology in the same study. Such integrations or combinations can finally allow the bulk of the mission-critical data and the operational aspects of a complex trial to snap into focus. It’s clear that only a handful of vendors and sponsors will be able to do it.

So as patients are randomized to particular arm of a trial, and are assigned drugs, a few companies may be able to watch the data trickle in and manage supplies as if large trials actually were managed, and not just allowed to unfold.

Supply Chain Visibility

ClinPhone feels its expertise in integrating its supply systems gives it a unique position in the market. Here’s how Byrom puts it: “We see a lot of EDC products that can do randomization. The vast majority of our business is doing randomization with the drug supply. There is a weakness in EDC that can only do randomization and not do the associated control of the medication and supply chain behind the scenes.”

ClinPhone’s David Stein, VP of product management, says the company’s middleware approach to integration is technically simpler, and more robust, even when competitors’ IVR and EDC systems must be connected in an integration procedure.

“It’s been the area of fastest growth,” Stein says. The company is actively working on 15 combination projects. He quickly sketches one trial in the central nervous system therapeutic area. It might be daunting for competitors to match: two countries, 300 patients, using integrated systems for IVR, EDC and electronic patient-reported outcomes.

Simpler Systems

ClinPhone’s vision is that IVR and EDC systems remain separate and distinct, to allow them to function (and be validated and maintained) properly. ClinPhone develops one middleware connector to get data out of a particular system. The middleware routes the data to a hub that distributes it to other systems that need it.

If an underlying system changes, only the ClinPhone connector (not the whole integration) needs to be updated. “Now you have only one connector to update,” says Stein. “By building the connectors, we have a more repeatable, more easily validated process in place.”

ClinPhone thinks that approach will reduce the number and severity of headaches for data managers and others charged with reconciling three or four streams from disparate clinical trial technology streams. The troubleshooting should be simpler, Stein says. “I have never seen a study where those four data streams lined up 100 percent,” says Stein. “There were always exceptions kicking out.”