Clinical data standards seem wonderful in the abstract. On a white board, the work of CDISC and HL7 should make life easier, cheaper and faster for everyone involved in any clinical trial, just as broccoli should be good for anybody’s health. Thinking about buying broccoli is more common than buying it. That’s surprising, given the FDA’s encouragement to use CDISC’s study data tabulation model (SDTM) standard. 

Almac, with headquarters in Northern Ireland, has been buying the broccoli and serving it. “Clients have their own standards. We are starting to see more and more where the standards are shifting to the SDTM,” says Sheldon Witmer, group leader in Almac Clinical Technologies clinical project services department.

Growing Confidence In EDC

The same is true of the use of electronic data capture (EDC) in general. “Most companies know this is the way to go,” he says. “They’re not questioning whether to do EDC. It’s how soon to do EDC. The types of questions are not so much centered around what’s going to happen to my data and security.”

Almac offers every major clinical technology needed by industry, including adaptive trial design, electronic data capture, interactive voice response (IVR), patient-reported outcomes (ePRO) and everything related to drug supply management, which is facilitated by a sister company under the 2,000-employee Almac Group umbrella. 

Unified Front

Witmer says Almac is not just talking about adaptive clinical trials; it’s deploying them using its IVR and drug supply tools and domain experts. “We are actually doing them,” he says.

“Electronic data capture is essential for a lot of these adaptive designs,” he adds. “When you’re using EDC, you’re getting your data a lot faster. It really aids an adaptive trial.” Referring to the sister division of Almac with deep expertise in managing the drug supply issues on adaptive studies, he says: “We provide a unified front and a main point of contact across both companies.” Some clients like an integrated Almac report that combines information from the IVR and supply systems.

Like an increasing number of companies that never made a big deal about ePRO, Almac’s technology arm is ramping up. “We’re doing a lot more work with e-diaries,” says Witmer. “That’s been a really big focus area. We’ve seen our business grow.”

FDA-ready PDFs

Back in May, the company announced a tool for archiving clinical data as part of the iTrial application, Almac’s EDC tool. It can save electronic case report forms (eCRFs) as PDFs. By itself, this is not groundbreaking functionality. But Almac’s export is more than a generic PDF, with the ability to see the audit trial. Better still, it’s easy to just view the data that have changed—or just the comments associated with changed data.

“We can select whether we want all of the data, just a particular site’s information or drill down to certain subjects, forms or particular subjects at a given site,” says Witmer. The PDF, of course, is independent of the iTrial software, giving some sponsors peace of mind should the data ever need to be re-inspected in 17 years and the iTrial application were not available. 

IVR, EDC Combo

The export tool is also suitable for compiling the case report form (CRF) component of what is sent to regulators. Says Witmer: “We’ve taken feedback from previous versions of the tool and the new guidances and incorporated that into a document that we believe has all of the information that will be necessary for a submission to the FDA.”

Witmer is especially proud of the companies all-in-one system for interactive voice response, which allows users to switch between phone and internet fluidly. “You can use the worldwide web in the morning and the phone in the evening,” he says. Almac calls that product IXRS, for which the ‘X’ is a variable.

Quick-Start Tool

Finally, the company recently announced a fast way to get started with IVR called IXR Express. It’s a preconfigured product that combines IVR, randomization and supply management.

The company says IXR Express customers can have all that up and running in weeks to handle “even the most aggressive timelines.” In the press release about it, Jim Murphy, president of Almac Clinical Technologies, called IXR Express “a solution that allows sponsors to accelerate the study start-up process without surrendering their ability to have the right solution to meet the needs of their study.”

Joe Cunningham, director of business development at Almac Clinical Technologies, says the company is typically able to start IXR Express studies four weeks after the user requirements are known, with some trials starting in as little as a week. The software represents the distillation of all the company’s collective experience. In an out-of-the-box way, IXR Express can support moderately complex studies without customization. Pricing depends on the complexity of the trial, naturally. But it tends to be lower than what Almac charges for a traditional, custom-designed project. “It’s more cost effective,” says Cunningham.