Later this week, on Thursday, the electronic data capture firm TrialStat! and biostatistical software house Cytel’s Jerald Schindler, president of that company’s Pharmaceutical Research Division, will be participating in a webinar on EDC and adaptive trials. ClinPage will moderate the discussion. You can sign up here. It’s free.

As we’ve written here, Schindler is probably the most articulate exponent of adaptive designs in the industry. The webinar will address one of our favorite topics. To wit, the dependence of advanced biostatistical techniques on real-time data and a robust clinical trial infrastructure.

TrialStat!, for those unfamiliar with the firm, is based in that high-tech haven of … Ottawa. Yes, Ottawa. It’s in a wonderful, civilized country called … Canada. Ottawa, Canada, is a major city north of Ohio. The company is doing EDC in Canada, the U.S. and Europe.

And it’s thriving. The firm’s headcount has doubled over the past year. TrialStat! says it is winning business from competitors with its completely web-based, hosted EDC tool, which the company periodically uses to bail out other EDC companies on rescue projects.

Rapid Expansion

“Business has been really good,” says Jonathan Barker, TrialStat!’s CEO. He thinks the entire industry is experiencing robust growth with a new level of acceptance of EDC. “Our expectations have been exceeded for the last couple of years. In the last year, we’ve cracked the threshold. Clients in a significant part of the industry have a clear idea of what EDC makes possible.” 

Barker still views the industry as wide-open, estimating that perhaps two thirds of the market has not been claimed by any EDC supplier.

Among customers, he reports, one recurring theme is the rapid study startup time. “We have an offering that is significantly faster than anything our clients have dealt with in the past,” notes Barker. Dragging and dropping the elements of a protocol, designing the CRFs—using his software, it can be done in a morning. Interim analyses and study closeouts are equally fast, he says.

Among other features, TrialStat’s application has been integrated with hand-held barcode readers for easy use in hospitals. It also has image-based data capture, allowing health care professionals to tap an image of the human form to indicate the location of a patient’s pain.

Avoiding IT

“No programming skills are required,” says Barker. “We’re the IT guys. No one really wants a relationship with their IT guys. Our strategic goal as a company is to eliminate, as much as possible, the aggravation and headache that go along with using IT tools. That’s been a fundamental premise of our platform.”

So with TrialStat!, there is zero software to install. “Software as a service,” or SAAS, is hardly new. But Barker says his team has built an especially potent example.

It is not uncommon for clients to be up and running in a week or less. “You can design the structure of the clinical study in the morning, populate the range limits and do the validation in a few days,” says Barker. “You can deploy a study very quickly. We’ve understood that is not the case for others in the industry.”

Zero Footprint

“We are pure SAAS,” he adds. That means there is absolutely no software to install; it all runs over the web. “Many so-called SAAS are in fact a fat client installed somewhere. The fat client is used to do the design and create the study structure.”

As with some other technology suppliers in the industry, TrialStat! recognizes the complex dynamics between contract research organizations (CROs) and technology companies. Barker says the key is that the CRO staff with special areas of expertise can use his software to capture revenue that might have leaked elsewhere.

Regional Complexity

“The client, based on the skill set of the existing team they have, can make the decision to take the design-build component, and take that line item from being a charge-through and convert that to being a revenue item for the CRO,” he says. The same can be true of a sponsor with in-house expertise. “If they can do that in-house without sacrificing any quality, it’s a distinct advantage.”

Barker is an attorney by training, and says that the company’s roots in Canada may have afforded it another advantage as it grows in Europe during a period in which electronic health records seem poised to be incorporated in industry research. The company’s systems can be easily tailored to conform to various geographical and regulatory jurisdictions.

In Canada, he goes on to say, the regional provinces have their own health authorities, just as individual European countries have their own rules under the auspices of the EMEA. That’s prepared TrialStat! for complex global trials.  “The administrative overhead in dealing with multi-jurisdictional studies is much more complex. We have a very flexible design tool,” Barker says. “It is a straightforward thing for us to handle.”

New Drivers

Now that the industry is embracing EDC in earnest, he says, there is a reversal of sorts, with sponsors asserting their authority in some cases. “Clients are starting to drive the features and capabilities they want to bring on board to simplify their business processes,” says Barker. “Clients are going to be driving how they want their EDC platforms to evolve.”

Barker says the data standards of CDISC can simplify the process of his firm taking on a rescue study. Rescue studies, he says, are a specialty at TrialStat! “We do a fair amount of those. If [the customer] has been living a life of sorrow with another vendor, or paper, often the common denominator to extract a portion of useful information is to use CDISC. This is something that the industry can really use.”

Rescue Me

Are there any generalizations about rescue studies? Apparently not. Most such customers have endured unsatisfactory service for months or longer, uncertain about the difficulty of pulling the plug. “These are always very, very painful circumstances,” says Barker. “The problems that generate a need to switch platforms are as varied as the clients.”

But sometimes a painful decision leads to something over the long haul. Says Barker: “Our ability to deploy a new study very, very quickly and work with the CDISC standards gives them the view that it is the shortest amount of additional pain they are going to have to go through to get the study back on track.”

Editor’s note: On the webinar this Thursday, TrialStat’s chief scientist, Khaled El Emam, will be explaining a bit more about what makes his company able to support adaptive trials.