Leading provider of advanced EDC solutions for clinical trial management to demonstrate safety, efficiency and speed of revolutionary online adjudication capabilities available in its Veracity™ clinical asset management system
Boston, Mass. – June 15, 2009 – KIKA Clinical Solutions, the leading provider of advanced EDC solutionsfor clinical trials, will demonstrate its unique online adjudication capabilities at the DIA 45th Annual Meeting, June 21-25 in San Diego, in Booth #1247.
Online adjudication is one of the most exciting developments made possible by EDC. It is exclusive to KIKA’s landmark Veracity system for outsourced clinical trial management.
Adjudication is the review of an event reported at a site by one or several experts in a clinical trial. It is performed to improve the reliability of assessments subject to interpretation.
Traditional adjudication is long and expensive. Global company OrbusNeich B.V designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases.
Ursula Morjaria is Director of Clinical Research Europe for OrbusNeich Medical B.V, Ms. Morjaria explained, “When we used traditional adjudication in a late-stage trial, it took weeks to freeze the internal database. We sent a binder to each study member, and they had to complete their spreadsheets separately and send them back. Or, we tried to schedule in-person reviews.”
Until a few years ago adjudication often was omitted from the EDC workflow because it required features that were not available in existing platforms.
Only KIKA has made online adjudication a vital component of EDC, successfully implemented in thousands of cases in oncology, cardiovascular, urology, radiology, neuroradiology and orthopedics.
Safety and Time to Market
Online adjudication offers full access to all data collected, providing a comprehensive review and enabling early detection of discrepancies. It accelerates the delivery of primary or secondary endpoints because it is a real-time process. Data collected is better quality, and there is a shorter time between event and adjudication.
Cost
Online adjudication offers time, quality and cost improvement on large cohorts. There is no need to set up another system because it is fully integrated. It reduces the need for physical meetings and virtually eliminates shipping costs because documents and reports are online.
Flexibility
Combining EDC and online adjudication is a complete approach to clinical asset management. If a definition changes in the middle of a trial, a project manager can create an interim report quickly, and merge data into one table.
Compliance
Online adjudication addresses new clinical challenges, including regulatory agencies requesting large-scale post-marketing surveillance programs.
KIKA CEO Linda Beneze explained, “Sponsors who use our Veracity Clinical Asset Management platform for online adjudication get their study documents online as they arrive. They have a tracking system that creates custom, dynamic reports. Members meet online whenever necessary. Online adjudication is delivering significant safety, time and compliance benefits for clinical asset management.”
About KIKA Clinical Solutions
KIKA helps the world's most innovative biopharmaceutical and medical device organizations bring much-needed medical solutions to the market faster. KIKA’s Clinical Asset Management platform provides unmatched flexibility and customization with advanced EDC including images and online adjudication. For more information, visit www.kikaclinicalsolutions.com.
KIKA and Veracity are trademarks of the KIKA group of companies.
Media contact: Brenda Nashawaty, bnashawaty@kikamedical.com, 617-688-3253