ICM Adds Drug Safety Module To VIZYX Compliance Management Suite

Atlanta - ICM has released a drug safety module to VIZYX, an integrated compliance management software suite developed exclusively for life sciences companies. Integrated seamlessly with the VIZYX platform, VIZYX.ds enables medical affairs and drug safety departments to capture, process and report all adverse events simply, quickly and accurately. The new module ensures that all regulatory reporting deadlines and requirements are met without further burdening already over-burdened drug safety personnel.

"Companies bringing new drugs to market are under increased pressure to keep costs down, even as regulatory compliance demands - and the risks and costs associated with non-compliance - increase," said Ramon J. Dempers, ICM President and CEO. "VIZYX.ds links all safety personnel electronically, speeding information gathering and delivery, while preventing delays. Cases move through the process more quickly, and workers are alerted should cases fall behind."

The rules engine also escalates the identification of serious Adverse Events and routes them through a high priority process, all of which helps ensure that FDA and corporate deadlines are met.

The drug safety module integrates seamlessly with the VIZYX platform, which provides the framework of functionality, features and management tools shared by all VIZYX modules. VIZYX.ds also integrates with the VIZYX data warehouse module (VIZYX.dw) to provide accurate trending and alerting on all aspects of the regulated environment.

"Legacy systems each provide only one piece of the compliance puzzle, and getting them to work together is complex and costly," said Dempers. "VIZYX provides even small and medium-sized companies with the system to meet all of their compliance needs. The different modules - document management, drug safety, event management - all talk to each other."

As with all VIZYX modules, VIZYX.ds uses Microsoft interfaces as its primary user interface, increasing the speed of user acceptance, while keeping training costs down. Companies continue to use their own forms and reports. The system provides a searchable database to track trends and provide information on medical, technical and adverse events. Moreover, users do not have to be able to write reports to get meaningful information from the system.

Installation of VIZYX.ds takes as little as 90-120 days, a significantly shorter period compared to other systems. And VIZYX.ds ships with validation scripts ready to execute. ICM also provides extensive customization validation support and training services to ensure a smooth transition.

SOURCE: ICM Corporation