Before the Food and Drugs Administration (FDA) is able to clear the road for new drugs to enter the market, they first are extensively tried and tested by clinical development organizations. Procedures such as clinical data management, adverse event surveillance, statistical analysis, and regulatory submissions, have to be performed in an integrated clinical development systems environment. In order to enhance the productivity and pace of the entire process, Sun Microsystems and NetForce have joined forces to design a Clinical Systems Integration Centre (CSIC). CSIC allows pharmaceutical companies to use state-of-the-art application software from several manufacturers for integrated management of drug trials, harmonized data access and distributed operations.
The ever more rapidly developing international drugs planning and production, forces the pharmaceutical firms to optimise the level of scalability within their clinical information systems infrastructure. CSIC is considered to be an ideal tool for the streamlining and speeding up of the overall clinical development process. It is based in San Francisco, where the NetForce company operates as its host and systems integrator. This firm is also responsible for the design of EventNet, which constitutes an innovative adverse event (AE) reporting and safety surveillance database architecture. The distributed and partitioned environment permits biotechnology concerns with worldwide partners to operate across company firewalls by means of a real-time case update mechanism.
NetForce has been working together with software developer Actuate in order to integrate the Actuate Reporting System into EventNet. This enables the request and creation of drug safety and management reports to be viewed and printed. The recent connection of Actuate with Brio Query offers the EventNet users a chance to unsuspected safety data reviewing and exploring possibilities. The architecture equally includes features for large-scale query-by-example, workflow and security. Oracle Clinical data and trial management software is the second package which is introduced to EventNet for implementation with the AE application.
BDM International, as a third partner, has developed the AutoCode CS software for efficient coding of AE narratives. Analysis and display tools are provided by SAS, since this institute forms the industrial standard for statistical tools and applications. Currently, integration of the SAS product Ph-Clinical with both EventNet and Oracle Clinical is being investigated. Netforce and Sun Microsystems still are looking for other software partners to further improve the clinical workflow, document management, clinical trials simulation, and drug development project management of CSIC.
The complete range of clinical applications integrated into the CSIC is running on the Sun 4-processor Enterprise 5000 database server, operating as a practical demonstration and performance analysis platform with the necessary storage and networking facilities. The platform is perfectly suited for bioinformatics, chemical structure data management, data analysis and reporting, and document management for the introduction of new drug applications to regulatory authorities. In fact, CSIC provides the one and only venue for the industry to monitor their drug trials in a fully equipped clinical development systems environment.