AdWATCH Rapidly Manages and Accurately Reports Adverse Events

adWATCH, from Winchester Business Systems, Inc. effectively meets the challenges of managing and reporting adverse events during clinical trials and after product introduction.

AdWATCH Rapidly Manages and Accurately Reports
Adverse Events

Winchester Business Systems software is the leading
solution for pharmaceutical organizations

WINCHESTER, MA, (May 6, 2002): adWATCH, from Winchester Business Systems, Inc. (www.wbsnet.com), effectively meets the challenges of managing and reporting adverse events during clinical trials and after product introduction. Recently, a major drug product recall was ordered for a high-profile drug company in the Boston area. The FDA knew more than the drug company about the product's adverse events and product complaints. Health professionals had reported adverse events directly to the agency and had not always informed the company. Some of the adverse event reports originated in other countries. The company was painfully surprised when the FDA insisted on a costly and embarrassing recall.

Complaints Must be Reported to Both the Manufacturer and the FDA.
The safety of several hundred thousand patients is at stake.

Winchester has focused its safety system development efforts on helping the industry solve the complaint processing problems in an efficient, cost-effective manner. In February 2002, "FOCUS", the monthly magazine of the Regulatory Affairs Professionals Society (RAPS), Ms. Meredith S. Brown, RAC, provided a review of the product complaint problem. According to Ms. Brown's survey, each large pharmaceutical and medical device company, over $1 billion sales annually, processes more than 12,000 product complaints a year. Small medical device manufacturers with sales less than $1 billion annually process between 1,000 and 3,000 product complaints a year.

At a recent conference on Adverse Drug Reactions, Dr. Stanley Garbus, Chief
Medical Officer of Sentrx Inc., a firm in Little Falls, New Jersey that
specializes in Drug Safety Surveillance, stated, "Only 40 percent of
adverse events that are reported by health professionals to the FDA are
also reported to the manufacturer." And recent studies show that only one out of ten adverse events gets reported to the FDA.

Recalls, closed-up companies, fines, and agency letters are the result. When the FDA asks a drug company, biotech, or medical device manufacturer a
question, a rapid response is expected. Every company, regardless of size, that develops and sells products in the pharmaceutical or medical device marketplace must have a computerized product complaint and adverse event reporting system.

Winchester Business Systems Meets the Rigorous Challenge

AdWATCH, from Winchester Business Systems, is the software solution for pharmaceutical organizations to manage and report adverse events that occur during and after clinical trials. adWATCH gives the reporter at a clinic, hospital, or investigative site a fast and effective means of alerting sponsor drug companies to adverse events as they occur, in real time. Adverse Events can be generated, managed, and electronically reported to the regulatory departments and government agencies.

Winchester's adWATCH system also forms the centerpiece of a company's
Corrective and Preventive Action (CAPA) program that is mandated by the
FDA. adWATCH easily expands to incorporate all of the components of a
company's quality system.

About Winchester Business Systems

Winchester Business Systems, the leader in providing technology solutions
to pharmaceutical companies worldwide, delivers customized software that
increases efficiencies and reduces delays and costs. Mike Regentz, CEO of
Winchester Business Systems is available to speak with you about adWATCH,
other challenges and solutions for the pharmaceutical industry, and successful customer references.

Contact: Nancy Sarles
Winchester Business Systems
Ph: 781-631-6416
Fax: 781-631-2537
Nsarles@attbi.com
http://www.wbsnet.com

Mike Regentz
Managing Director
Winchester Business Systems, Inc.
1-781-729-7150 Ext. 105
Mike_Regentz@wbsnet.com
http://www.wbsnet.com --