With the latest release of ClinicalAnalytics, Ottawa, ON-based TrialStat Corp. “extends the footprint” of its electronic data capture (EDC) platform to cover a broader spectrum of data and study management, reports CEO Jonathan Barker.

This update to ClinicalAnalytics 4 (CA 4) is the “most significant enhancement we’ve done,” says Barker, and will likely be “quite disruptive” because the software does the work it used to take four or five separate systems to accomplish.

Jonathan Barker

Among the most significant improvements is the ability to easily evaluate data from multiple study sources within a project and aggregate that data into sophisticated, real-time graphical reports to identify trends and anomalies, says Barker. All that’s required of users is to “click and drag” the desired form, data elements, and preferred visualization format.

Users can view demographic data aggregated by country, site, or group, Barker says. Audit trail summaries enable users to review all study subject data, including changes made throughout the study.

CA 4 also now incorporates “integrated post data entry validation,” allowing users to “create rules to run against all data in the database and to automatically create DCFs [data clarification forms] where required” as a study progresses rather than at its completion, says Barker. For example, they can see changes to patients’ blood values from visit to visit that might be indicative of a drug-related adverse event, or ensure that enrollees match the gender and age specifications in the study protocol. Getting data validated earlier “dramatically speeds the time from last-patient-last-visit to database lock.”

With many EDC platforms, sponsor companies are “forced to export data sets to SAS or an Oracle Clinical data management system to do this,” says John Simpson, TrialStat’s director of product strategy. The validation exercise may result in data clarification requests that can be generated – on a single subject, if need be -- “with the click of a mouse.”

In terms of study management, CA 4 lets users better control access to electronic case report forms via user permission interfaces, says Simpson. When subsets of forms need independent analysis or central review, viewing of all other information is fully shielded. CA 4 also allows for customization of study designs in the way dates and times are handled.

The new features are “all delivered through the same SAAS [software-as-a-service] model” ClinicalAnalytics helped popularize, says Barker. The entire application, from design to deployment, functions through a Web browser. That eliminates the capital requirements for infrastructure and the need for an IT team to manage it. “No programming is required. Efficiency is at the heart of all we do.”

With CA 4, “there’s no longer a need to export data to a clinical data management system, maintain a separate system for randomization, or to perform data validation checks, or to export data to any kind of modeling tool,” says Barker. “We’ve also replaced some clinical trial management system capabilities.”

Barker adds: “This new release takes CA to a higher level of performance and flexibility, delivering a best-in-class, on-demand solution at a fraction of the cost of comparable EDC applications.”

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