Is everything coming together? Apparently.

As we wrote last week in this story about ClinPhone, the integration of two central clinical technologies—electronic data capture (EDC) and randomization—is in the air. Firms like Clarix, DataTrak and etrials have their own approaches, which typically involve a single database. 

Almac Clinical Technologies, like ClinPhone, is yoking together two systems that can be independently validated and maintained. Almac’s technology division, of course, is part of Northern Ireland’s Almac Group of companies; Fritz Haas is its Pennsylvania-based VP of new products and services. “As an industry, we’re moving in a direction where things are much more highly integrated,” says Haas. “The integration trend is something we’re very much a part of.”

Fewer Suppliers?

Haas says some sponsors now prefer one-stop shopping for clinical trial technologies. He predicts that weaker vendors offering a single product may find a rockier path in the years ahead. “People in the one-solution environment are in a tough place in the market,” he says.

Almac has an “IXR Express” offering, designed for sponsors that do not require the most ornate or baroque customization of their trials. “IXR Express” is a faster way to get started with randomization via the telephone or the internet (which explains the “X” instead of the usual I-V-R). Now Almac has added an EDC option to that “Express” offering, without changing the speed. “These are designed to be as fast and straightforward as possible,” says Haas of the trials in “Express” mode. “We have a great deal of prebuilt functionality.”

“If we’re able to keep the clients within the confines of a pretty large area,” Haas says, “we can get systems up and running much faster than industry average. We’re talking about two to three weeks from start to finish. That took a lot of work.”

A Schism

Haas says Almac is seeing a split in the market. Some customers still want the ability to customize every last detail. That segment of the market will always be a factor; Almac’s technology group and its four sister companies will always be happy to serve it.

But the company doesn’t want to ignore customers who are interested in lower costs and greater speed. “We do want to add an increasing number of things at the other end of the market as well,” Haas says. “A small biotech may want to see if they can put something together quickly and run in a much leaner environment. We’re ready for that.”

Down The Chain

Like ClinPhone, Almac offers the ability to manage drug supplies in a trial. In Almac’s case, it’s a separate division of the corporate family that specializes only in supplies. Since the vagaries of drug supply can be driven by randomization and patient recruitment, some customers will be watching and managing shipments electronically in ways that have not been possible before.

Such visibility extends beyond shipping depots at the country level, and into single sites and even, potentially, the medicine cabinets of individual patients. That’s because Almac also offers a phone- and web-based electronic-patient-reported outcome (ePRO) solution that can record when medications are consumed. “That entire supply chain is now visible to people running the trial,” he says. “That’s looking at the supply chain from the individual patient’s usage all the way back to manufacturing.”

Haas hastens to say that supplies are not shipped automatically, simply because sponsors like a person with a comprehensive view of the trial to set the logistics in motion.

Frustration Factor

This sort of integration could have especially powerful ramifications for biotech sponsors, Haas says, owing to the much more expensive process to generate their trial supplies. Says Haas: “The idea is to try to minimize the amount of production and optimize the distribution so you’re doing things as efficiently as you possibly can.”

Haas says the systems are sufficiently robust to not need a sheet of paper, but the company isn’t rushing anyone. The sponsor community often wants a cellulose-based security blanket, even if the most up-to-date data are on a server somewhere. “It’s entirely possible to do everything we just spoke about without using paper,” says Haas. “Paper is still a comfort thing. They feel more comfortable having paper in their hands.”

Do customers ever complain about having too many suppliers? Is there frustration? “It’s high,” Haas says. “It’s been verbalized. You have someone who is trying to run a trial, and they’re dealing with three different vendors. And something goes wrong. There can be an unwillingness on the part of vendors to take responsibility. They’ll say, that’s not us—it’s that person.”

Enter Data Once

In the case of the combination of its EDC and IVR, he says, a key notion is the avoidance of forcing sites to populate two systems with data. “The two systems work very well together,” Haas says. And of course Almac will shoulder the responsibility for both systems, making it impossible to shift the blame.

Beyond the technology, Haas says, the processes to get the trial completed are also being unified in ways that conform to the work flow of the client. Says Haas: “We are not thinking about this in terms of we offer this technology or that technology. We’re looking at what the clients are having to do in their world. We’re making our processes and technology map to their needs.”

There is not yet one user name and password, but that is on the drawing board.

Judicious Expansion

The Clinical Technologies group at Almac has been growing nicely, Haas says. But he doesn’t want anyone to think the expansion is out of hand. “We have learned that if you’re not in controlled growth, you can get overwhelmed,” Haas says.

“We try to be careful not to overextend ourselves,” he adds. “We want to keep our service level and quality high. Our largest competitors in the IVR space have had stumbling. You have to keep an eye on how far and quickly you are trying to expand and not get ahead of what your infrastructure can support.”

That conservative approach to growth is a reflection of the beliefs of the company’s founder, Sir Allen McClay, the founder of Galen Pharmaceuticals. He started Almac in 2002 using his own funds. “He is trying to build something that is for the betterment of mankind,” says Haas. “It puts your work in a different perspective.”

Editor’s note: This is an earlier article about Almac’s quick start tools and a new location in Pennsylvania.