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January 10, 2003 For Immediate Release Contact: Gene Pinder at (919) 678-9099
INTEGRATED SAFETY SYSTEMS, INC. ANNOUNCES PHARMACOVIGILANCE SERVICES
North Carolina company collects, evaluates, and reports serious adverse events as part of its comprehensive safety surveillance services
(Research Triangle Park, NC) – Integrated Safety Systems, Inc., (ISS) a safety surveillance and consulting firm for pharmaceutical, biologic and medical device companies, announces pharmacovigilance services for collecting, evaluating, and reporting serious adverse events.
The new service means ISS can handle all safety monitoring requirements for its clients as mandated by the Federal Drug Administration (FDA). With its E2B-compliant, validated SAE electronic database system, ISS is able to track and process every reported serious adverse event seven days a week, 24 hours a day. Under the direct supervision of a trained physician, all data that are captured by ISS are also stored and backed up for its client’s security and safekeeping.
In addition to providing electronic database services as part of its pharmacovigilance efforts, ISS also prepares expedited and periodic reports.
About ISS, Inc.
Located in Research Triangle Park, North Carolina, Integrated Safety Systems, Inc. (ISS, Inc.) is a full-service safety surveillance company. Besides collecting, evaluating and reporting serious adverse events, ISS also provides medical monitoring and consulting services, along with medical writing, NDA-related activities (including preparation of the Integrated Summary of Safety), coding and safety training. Its clients include small-, mid-, and large-sized pharmaceutical, biologic, and medical device companies, including biotechnology startups. ISS is led by president and CEO Dr. Mike Klepper, a physician with 20 years of global, medical product safety experience.
For more information, visit the company’s website at www.issdrugsafety.com or call (919) 678-9099.
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