On July 12, 2004 Organon finalized a global implementation of ISI’s CRFTrack clinical imaging solution to help manage their clinical development in both Oss, Netherlands and Roseland, NJ. The project, over two years in development, evolved from Organon’s search for potential vendors to help them meet their increasing requirements to efficiently manage their growing clinical data across their global enterprise. After extensive review of more than 70 vendors, Organon felt that ISI’s flagship clinical document imaging, management, tracking and reporting application, CRFTrack, met their needs.

By implementing CRFTrack, Organon feels it is now better able to manage the ever-increasing number of Case Report Forms (CRF’s) associated with their clinical development process. CRFTrack will ensure document availability and security within Organon’s data entry, data management, and clinical documentation departments. Furthermore, CRFTrack’s Web View feature will facilitate safe document-sharing for well over a million CRF images across Organon’s global enterprise and with regulatory bodies worldwide. Accordingly, through parallel processing and the elimination of traditional methods of sharing documents, Organon will be able to realize shorter timeframes for data query resolution, less redundancy and greater productivity.

This implementation represents a major step for Organon in streamlining their global CRF management and review processes, and provides a strong foundation and opportunity for further improvements by Organon to leverage the additional functionalities of CRFTrack such as split screen data entry into OracleClinical, remote scanning and electronic workflow. The installation and validation of the system was done in an unprecedented and aggressive six-month timeframe and consisted of a three-tiered validation process performed simultaneously in the Netherlands and the US.