SOURCE: KIKA Clinical Solutions

December 17, 2009 09:00 ET

KIKA Clinical Solutions Veracity EDC System Chosen to Improve Data Quality in Accuray CyberKnife® Radiosurgery Clinical Studies

Web-Based Veracity's Centralized Imaging and Database Capabilities Expected to Streamline Credentialing and Quality Assurance

BOSTON, MA--(Marketwire - December 17, 2009) - KIKA Clinical Solutions announced that global radiosurgery leader Accuray Incorporated (NASDAQ: ARAY) has chosen KIKA's Veracity™ Web-based EDC system to improve data quality and decision making on clinical studies that use Accuray's CyberKnife® Robotic Radiosurgery System. KIKA is the leading provider of advanced EDC solutions for clinical trials.

Accuray, based in Sunnyvale, Calif., developed and markets the CyberKnife System to extend the benefits of radiosurgery to include extracranial tumors. The CyberKnife System has been used to treat more than 70,000 patients in hospitals in the Americas, Europe and Asia. Accuray migrated to the Veracity™ EDC system based on its successful application of KIKA's prior clinical trial management product called Eventa™.

In participating CyberKnife System clinical studies, Veracity™'s database will complete the central imaging review and completely manage the approval process.

Imaging plays a vital role in CyberKnife System clinical studies. Diagnostic images identify the target and help determine patient eligibility criteria. Treatment images aid in the development and delivery of a treatment plan. Follow-up images help to assess treatment response. Imaging also is vital in physics credentialing and quality assurance.

Joanne Davis, Ph.D., Director of Clinical Programs at Accuray, explained Veracity's benefits: "Imaging review for multicenter clinical studies creates a variation in image interpretation and analysis. Central review and database management provides a streamlined process for credentialing and quality assurance. Participants are guided through the system to ensure there are no missing data. It decreases the time required to submit and review plans, and ensures that participants are properly trained and able to design quality patient treatment plans that adhere to protocol guidelines."

KIKA's Veracity™ is a highly configurable, collaborative platform. It enables all clinical trial stakeholders to collect, monitor, adjudicate, analyze and manage clinical study data in real time and store them into a CDISC-ready database. Veracity™'s imaging capabilities replace outmoded, inaccurate and slow methods such as courier services or FTP sites. Additionally, Veracity™ is supported by an ISO-certified quality environment. It enables regulatory compliance including 21 CFR Part 11.

KIKA CEO Linda Beneze said, "We're pleased that Veracity will be part of Accuray's groundbreaking radiosurgery success. Only Veracity can guarantee the most accurate, timely and detailed clinical trial data."

About KIKA Clinical Solutions

KIKA helps the world's most innovative biopharmaceutical and medical device organizations use advanced EDC solutions to bring much-needed medical solutions to market faster. KIKA's Veracity™ is the leading-edge Web-based clinical trial software platform that delivers Clinical Asset Management™ for any size clinical trial. Veracity is customized to meet study needs precisely. It provides unmatched flexibility and customization with advanced EDC including images and online adjudication. Veracity is backed by the industry's most reliable IT infrastructure and a world class Professional Services organization. For more information, visit

KIKA, Veracity and Clinical Asset Management are trademarks of the KIKA group of companies.

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