It’s one thing to get the data into an electronic data capture (EDC) system.

But in the battle to differentiate themselves, the providers of the pivotal technology are now trying to focus on the ease (or lack thereof) of getting data out. Which is why TrialStat has released an enhanced version of Clinical Analytics (CA), its web-based EDC product.

“We believe that the latest version of CA 4.0 will change the way people think about EDC,” Jonathan Barker, TrialStat’s president and CEO, said in a news release.

“We’ve tried to add lots of functionality, but our focus is on speed and flexibility,” John Simpson told ClinPage. He is TrialStat’s director of product strategy. With the new enhancements, Simpson says, the company’s ideals were super-easy Google applications such as Docs, Analytics and Gmail. “You have to have lofty goals,” he says.

Easy Reports

“We’ve put a whole new study reporting module in place,” Simpson adds. “It brings the data in the EDC system to life through a very usable user interface.”

TrialStat is also ramping up the rhetoric. “We feel we have the most usable solution,” Simpson says. “EDC is blamed for lack of recruitment at sites. Sites that are reluctant to use a complex EDC system will slow down or stop recruiting.”

Drilling Down

As Simpson put the new program through its paces, it was indeed simple. He quickly aggregated data by site, center or nation; he could also drill into the data and quickly arrive at patient-level screens. Need to find all the male subjects under 30 years of age in Pittsburgh? No problem. There are a few easy screens for custom variables. All reports can be saved and used on other trials. “I can drag in formulas if I choose,” says Simpson. “It’s all very intuitive. There is no programming required.”

The company already embeds randomization and patient-reported outcome (PRO) in its EDC solution. But with the new enhancements, it is judiciously adding features that encroach on the realm of two additional types of software. It’s incorporating both elements of clinical data management systems (like Oracle Clinical and Clintrial) as well as the clinical trial management system (like Perceptive Informatics’ Impact or ClinPhone’s CTMS).

“Clinical operations people could be using this to justify a study amendment or managing the study as they go,” said Simpson of the new reporting functionality. “The sites could see the data for their site in a very user friendly way. Monitors could use this to prepare for monitoring visits.” Investigators working on registries could use the TrialStat software for their own reports.

CDMS, CTMS Aspects

Simpson notes that some of the analytical and reporting functionality could be linked to investigator payments. The company’s EDC platform includes triggers that fire upon the completion of a particular milestone. “The same function that we use to generate CIOMS or Medwatch forms could generate payment forms when a specific point has been reached in the study,” he says.

Pointedly, Simpson notes that there is nothing that has to be requested from or programmed by TrialStat. Ordinary users will be able to run the new reports themselves. “They will actually have real-time access. You don’t need to request access from an EDC provider to get access to your information. It’s available to customers 24/7.” To emphasize the ongoing, electronic nature of its service, the Ottawa, Canada firm doesn’t market itself as an EDC vendor but as a “clinical data solutions on demand” provider.

Raising The Bar

In some cases, TrialStat expects users will be running reports soon after data is entered. This appears to be an effort to help identify problematic data using more sophisticated techniques than are common in the EDC niche today.

By way of example, TrialStat is touting a feature called “Post Data Entry (PDE) Validation,” which allows data to be validated during the trial according to the study’s configuration rules—and, in a new twist, across multiple forms. This goes beyond merely changing an icon from yellow to red, or from an open padlock to a closed one. The company’s news release notes: “This ability to run early validation of study data, rather than at the end of a study, can dramatically speed the time from last patient last visit (LPLV) to database lock.”

Google-Worthy Analytics

In a sense, TrialStat is trying to add sophisticated business intelligence and web-based analytical functionality that customers won’t have to buy elsewhere. The business intelligence software niche is hot at the moment, with key companies in the space being acquired or subject to speculation about being swallowed. Just last week, IBM bought Cognos for $5 billion.

Learning all that robust Cognos or Siebel reporting functionality may not be something that harried clinical professionals in the trenches of a busy trial have time for. Or the budget. “Many of the smaller biotechs and CROs don’t have access to any of the Cognos tools,” says Simpson. “Programming Cognos is not for the faint of heart. We have tried to make it drag and drop simple.”

Help For CROs

Some reports, Simpson says, have been designed specifically for contract research organizations (CROs). With major pharmas professing happiness with their EDC solutions, the thriving CRO industry appears to be an increasingly well-populated battleground for EDC vendors eager to win new customers.

The TrialStat system can easily generate reports that show missing data, data clarification form (DCF) status, query complexity, or data clarification forms per research center. Notes Simpson: “We can see when centers are using the product. If sites said they entered particular data, we can check to see if they did.”

He says some of the early feedback from prospective CRO customers has been favorable: “It gives our CRO customers a serious competitive advantage. They can allow their customers to design, support and deploy their own clinical trial.”