DLB Systems' ALERT 5 Improves Drug Safety Surveillance Processes.

LIBERTY CORNER, N.J.--(BUSINESS WIRE)--May 15, 1995--DLB Systems, Inc. announces the latest release of their drug safety and surveillance system: ALERT 5.

This version of ALERT incorporates a range of new features, emphasizing flexibility to the user above all else. With more than 40 pharmaceutical and biotechnology clients, upgrades to the ALERT system have been client and industry driver, guaranteeing a product that meets users needs as well as global regulatory reporting requirements.

Having gained his experience from the FDA and the pharmaceutical industry, Scott Hayes, DLB's Director of Regulatory Affairs, is well aware of the impact of this announcement, "ALERT 5 delivers just what the industry has been screaming for; a system that can be easily and rapidly re-configured as company practices or regulatory requirements change." This rapid re-configuration can help pharmaceutical and biotechnology companies reduce the time, cost and effort required to meet stringent global regulatory reporting requirements.

ALERT 5 utilizes the DLB Toolkit, which is also the basis for DLB's RECORDER system for clinical data management. The DLB Toolkit follows DLB's long-standing philosophy of using proven technology, open design, and sound methodologies. It is this toolkit that enables DLB to keep up with the rigorous demands of the industry.

The new ALERT release continues to support international drug safety monitoring through standard reports for regulatory agencies worldwide (such as FDA 3500A MedWatch; CIOMS I & II; pharmacovigilence, US Periodic and Increased Frequency reports; VAERS form; BGA form; and MCA "Yellow Card"); as well as data structures for all commonly used pharmaceutical dictionaries. ALERT 5 is the first safety system released with database structures to work with the new MEDDRA (Medical Dictionary for Drug Regulatory Affairs) dictionary. The flexibility of ALERT 5 allowed DLB to conduct workshops to assist industry professionals in evaluating MEDDRA by loading company data and automatically coding against WHO-ART, COSTART and ICD-9 dictionaries. Management reports, actions lists, audit facilities, validation routines, and a batch load utility continue to be standard.

The flexibility offered by ALERT 5 allows rapid system set-up and user re-configuration, without requiring programming skills. In particular, screens and data items can be added, modified, or masked to support company of product specific requirements, screen and data item order can match departmental workflow or printed forms, company nomenclature or local language can be used as screen prompts, and in-house developed or modified dictionary structures are supported. Supplied data validation and consistency checks can be amended or extended to specifically address each company's data cleaning, trend analysis and regulatory reporting needs. Most importantly, this customer configuration survives product upgrade by DLB.

Alert 5 can be integrated with RECORDER via common data structures and shared tables, enabling easy reconciliation of serious adverse event reports received via phone or fax, with the same event reported on a clinical case report form. This system can significantly streamline the processing of clinical adverse events.

In addition to ALERT and RECORDER, DLB's integrated product suite includes MONITOR and Field MONITOR for clinical trials and investigator site management. This suite provides a complete system solution for clinical development through post-approval surveillance. DLB's emphasis on product validation ensures compliance with international regulatory guidelines and criteria. DLB products have been implemented stand-alone and in integrated networks in more than 50 companies at over 100 sites in 21 countries.

CONTACT: DLB Systems, Inc.

Suzanne Bishop, 908/604-8604