Cambridge, Massachusetts-based Bolt Beranek & Newman Inc’s BBN Software Products Corp subsidiary has unveiled BBN/Clintrace Release 1.3, a program that reports and tracks adverse drug events. The company believes the application will enable drug companies to fulfill their drug licensing obligations more quickly by cutting down the time spent on what is fairly labour-intensive work, that is reporting and monitoring adverse reactions during drug trials. But BBN also believes that it can be used in post-marketing surveillance: most countries insist on a period of time following drug launch during which companies and doctors are beholden to report adverse effects related to the drug. Clintrace supports the US Food & Drug Administration guidelines and regulations for doing this, and European reporting standards developed by the Council of International Organisations of Medical Sciences, although each member of the European Union has its own particular reporting form. Clintrace is integrated with BBN /Clintrial, clinical trials data management software, and the Oracle relational database. Clintrace runs on Windows and Macintosh clients in mixed network environments. Users can tailor the software to meet their specific requirements by relabelling fields on screen, using spare database items, and partitioning the database to control access and simplify reporting by individual project or therapeutic area says the company. Clintrace 1.3 is available immediately, and the pricing begins at $35,000 for a client-server configuration.
