KCR, a CRO operating across 19 European countries and in the U.S., is developing an innovative clinical trial data platform based on the Clincase electronic data capture (EDC) and clinical data management (CDM) software by Quadratek Data Service.

The platform will be an intuitive and low maintenance tool for site and project management in the same environment that already is used for EDC, interactive web response system (IWRS), drug supply and investigational medicinal product (IMP) management. By operationalizing the Clincase technology, KCR will provide its clients with an innovative clinical trial management system (CTMS) platform assuring full electronic data access.

“Innovate or die—needless to say, the CRO industry cannot afford to ignore the words these days. We have to respond to market tendencies, but more importantly, we have to set up new trends by using an innovative approach to efficiently respond to old and new clinical trial execution challenges,” said Mike Jagielski, president and CEO of KCR. “Our cooperation project with Quadratek provides KCR with an advanced technology solution to respond to market needs such as risk based monitoring (RBM) or to industry efforts to increase the level of clinical trial transparency.”

KCR’s aim when starting the Clincase platform project was to set up a technology solution that combines high degree of adjustability to the client needs with low maintenance requirements.

The CTMS platform will provide transparency of processes and bring experience and know-how into one of the most work-intensive and data-heavy areas of a clinical trial. The CTMS will be integrated into the existing Clincase architecture. The end product will be an innovative system offering increased capacities for overall trial management while maintaining high-level functionalities for data management (DM) and IMP supervision. The solution also will deliver in-built randomization support.

Martin Nöör, KCR CTMS implementation lead, said, “Clinical studies are becoming more and more complex in the operating environment. The innovative CTMS platform will allow increased management and control over multi-centered, international clinical trials thanks to a repository hub, providing detailed information for risk assessment and mitigation. KCR will benefit from centralized and real-time access to metrics and Key Performance Indicators (KPIs) by obtaining excellent oversight of the project activities.”