BOSTON, MA and PARIS--(Marketwire - May 06, 2009) - Pharmaceutical, life sciences and medical device companies gathered to discuss clinical trial management innovations and trends at KIKA’s inaugural European User Group Meeting last week. KIKA is the leading provider of advanced EDC solutions for clinical trials.
KIKA assembled science, business and thought leaders for the two-day session at Chantilly, France for an agenda of presentations and breakout sessions on vital topics related to EDC in clinical trial management.
KIKA clients and partners shared their successful experiences with the company’s advanced EDC solutions in instructive case studies:
-- One sponsor cited a remarkable 90% compliance at the six-month follow up on a clinical trial with 15,175 patients at 320 sites in 56 countries. The sponsor believes that regulatory bodies are requesting larger, more complex studies because they can be managed with technologies like KIKA’s EDC solution. -- An investigator site reported that online adjudication is a vital component of advanced EDC because it gives direct access to many documents and images. Online adjudication eases workflow and improves the quality of the work. The well-known medical doctor offering the case study explained that when he receives an email with data that needs adjudication he can conduct a medication review, and conduct an SAE list investigation and resolution. Before KIKA’s EDC, adjudication was a time consuming, complex and inefficient process. Only some of the data were provided. Interaction between CEC members was more critical and offered low process quality. Now, the site uses EDC for a time efficient, convenient workflow in combination with CEC member interaction. All event-related documents are online. Independent adjudication takes place before full scale adjudication. -- In an 8,000-patient study, a top Medical Device company explained that EDC offers substantial value at the back end and estimated that they reduced the number of monitoring site visits up to 75% by using EDC. -- A KIKA CRO partner which has brought KIKA’s tools in-house to develop their own case report forms described the opportunities and challenges of working with EDC, citing the improved database lock time as a significant advantage.
Also at the meeting KIKA offered product overviews and demonstrations of the new version of its groundbreaking Veracity™ EDC solution. Veracity is the only Web-based clinical trial software platform that is customized to meet study needs precisely. Its Web services architecture enables Veracity to connect and communicate with other software and systems involved in a study.
KIKA CEO Linda Beneze said, “The meeting was an excellent opportunity for KIKA, our clients, and our partners to share experiences and future needs. We’re on a mission to establish KIKA as the international standard in advanced EDC for clinical trials. Maintaining active, strong relationships with clients and partners at meetings like this will enable us to continue offering the industry’s best products and professional services.”
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 is a trademark of KIKA Clinical Solutions, Inc.
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