Software provides on demand EDC platform.

Press Release Summary:

With on Demand Electronic Data Capture (EDC) and data management capabilities, Clinical Analytics v4.0(TM) helps enhance quality, accuracy, and security of customers' clinical trial data. Clinical Intell(TM) provides user configurable reporting across base and aggregated data sets, while dedicated DDE module offers streamlined data entry and conflict detection interfaces. Offered in 2 versions, software is designed for pharmaceutical/biotech companies, CROs, and academic institutions.

Original Press Release:

Trialstat Unveils Clinical Analytics 4.0(TM) with Enhanced on Demand Electronic Data Capture (EDC) and Data Management Features

OTTAWA, ON, October 5, 2006 -- TrialStat Corporation, a clinical data management on demand company, today announced the next version of ClinicalAnalytics, raising the performance bar for the integrated delivery of EDC and data management. Clinical Analytics (CA) 4.0, the latest version of TrialStat's on demand EDC platform, provides a suite of new features that further enhance the quality, accuracy and security of customers' clinical trial data, while automating its analysis and management. Using CA 4.0, pharmaceutical and biotech companies, contract research organizations (CROs) and academic institutions can access through the web or a handheld device an affordable and robust on demand EDC platform that scales with the specific needs of their research regardless of the therapeutic area or clinical phase.

"CA 4.0 reflects our integrated vision of EDC and data management, where the two can be seamlessly managed on demand to shorten time to market for new products and lower overall clinical research costs," said Jonathan Barker, President and CEO, TrialStat. "CA 4.0's new features reduce the complexity and cost of clinical research, while accelerating project startup and completion."

CA 4.0 offers a suite of clinical data management and enhanced security features. These new features include the following:

o Clinical Intell(TM) (CI): CI provides advanced, user configurable, reporting across base and aggregated data sets. Data is displayed in standard table formats, as well as in a comprehensive selection of charts and graph types. CI provides a fast, simple solution for accessing study data and providing decision support.

o Enhanced Double Data Entry: This dedicated DDE module improves support for studies that still use paper to capture all or some of their data by providing streamlined data entry and conflict detection interfaces.

o Integrated Post Data Entry Validation and DCF Generation: While CA 4.0 already delivers comprehensive data validation at the point of capture, this enhancement permits the design and use of complex validation rules that can be run against a full data set any time. The system also allows DCFs/queries to be automatically created based on a pre-defined rule set.

o Standard and Custom Data Dictionary Automation (DDA): The DDA module allows study managers to upload and use any standard dictionary, such as MedDRA and WHOART, in their projects. Form fields designated as coded feature a quick lookup interface to allow coding personnel to easily select dictionary terms rather than hand enter them. Customers can also migrate their custom dictionaries to CA 4.0.

o Industry-Leading On Demand Encryption: This sophisticated module obscures highly sensitive data elements, such as health card numbers, so that only users that created them and their colleagues at different research sites can view their details. This enables researchers to capture highly sensitive data elements, while satisfying the privacy and security requirements of regulatory and ethics bodies.

TrialStat is offering two versions of CA 4.0 for its customers. CA 4.0 Infinite(TM) is specifically designed for pharmaceutical and biotech companies and CROs and includes all the software's new data management features, while CA 4.0 Select(TM) allows academic institutions to choose la carte which new data management features they want.

TrialStat will release ClinicalAnalytics 4.0 to its customers in December.

Headquartered in Ottawa, Canada, TrialStat is a privately held company that delivers clinical data management on demand by combining its full suite of data management services with the company's software as a service products. CA 4.0 is a robust and scaleable clinical EDC on demand solution used by leading academic and contract research organizations. SRS 3.0(TM) automates systematic reviews using real-time collaboration and management tools to achieve transparent, auditable and reproducible results quickly and cost-effectively. For more information, please visit us at

For media inquiries, please contact:
Kathryn Schwab
Media Relations, TrialStat

Shelley Mullins
Media Relations, TrialStat


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