TOOLS

By Deborah Borfitz

Nov. 24, 2008 | Perceptive Informatics has just made some notable time-saving improvements to its specialized clinical trial management system (CTMS), all of which were developed based on feedback from the software’s current roster of over 40 company users. Version 2.1 of TrialWorks has updated functionality specific to reporting, data transfer, and analysis of study information, says President Steve Kent.

TrialWorks’ “My Reports” feature augments more than 175 standard, department-specific reports with an ad hoc reporting tool, allowing project teams to save and share reports of their own creation, says Kent. The upgrade also aligns the system with new reporting requirements of ClinicalTrials.gov, a registry of federally and privately supported clinical trials conducted worldwide. Furthermore, the system now offers greater flexibility to segment studies and information for analysis of clinical trial data.

Steve Kent

The system overall is “highly intuitive…leading novice users to the right places” to accomplish their desired task, says Kent. Set-up can be accomplished in a couple of hours. Occasional users require only a few minutes of training. Unlike large companies that favor customized solutions, smaller firms “want to have a system that is easily hosted or installed, which covers all the bases,” including completing the right documentation and accurately tracking trial expenses.

As a matter of economy, TrialWorks has Microsoft’s primary database platform, SQL Server, on its backend rather than rival Oracle, says Kent. Smaller companies don’t want and can’t afford to have information technology teams devoted to both brands of software.

In terms of both customers and revenue, TrialWorks (previously part of the ClinPhone product portfolio) has been growing at a 25 percent annual clip, says Kent. It has been used for thousands of clinical trials.

Ultimately, TrialWorks will be fully integrated into a single-access, common interface of the eClinical platform provided by Perceptive Informatics. For now, a new web interface is available with TrialWorks 2.1 to simplify “one-off uploads” of patient and visit data and case report form (CRF) status from other systems, says Kent. This was previously a manual exercise.

Perceptive Informatics recently enhanced its DataLabs Electronic Data Capture and Clinical Data Management System solution (also a previous ClinPhone product) so that it better integrates with other Perceptive systems, including ClinPhone Interactive Voice and Web Response Systems, IMPACT (its leading enterprise CTMS solution), and its Medical Imaging solution.

DataLabs version 4.3 has an archive export feature for easier management and storage of selected study information, says Kent, which is designed to speed data lockdown on large trials. Workflow also gains momentum from the system’s enhanced ability to streamline data verification. The DataLabs solution now has read-only fields to prohibit modification of data from other systems while allowing users to perform queries and calculations based on that data. Additionally, data clarification forms can be customized and branded by study managers.

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