RCN Associates, Inc. announces its direct and collaborative efforts in support of a Good Pharmacovigilance Process (GPVP).

March 17, 2003

RCN Associates, Inc. of Maryland has partnered with Relsys International, Inc. (www.relsys.net) of Irvine, California and QED Solutions, Inc. (www.qedrx.com) of Reston, Virginia, to produce the first spontaneous reporting system with a pharmacovigilance concept of operations.

Argus PVä is that system!

ARGUS-PVä a complete integrated system that supports a Good Pharmacovigilance Process (GPVP) for industry, from enhanced tools to collect quality information at the front end, through proportional statistical data evaluation tools and a complete signal work-up and documented environment. QED’s QScanä is imbedded to provide the data analyses and data-mining engines. ARGUS-PV is functionally an FDA-AERS system for the global pharmaceutical industry. Relsys’ ARGUS-PV supports this GPVP in a web-based, validated environment that focuses on drug safety as a clinical art. ARGUS-PV is a cost effective cornerstone for a corporate drug safety Risk Management Strategy.

Public health risk management of prescription drug products requires systematic solutions, from theory to practice, using good processes, good practices, quality data, and supporting IT systems. The cornerstone of a risk management strategy is a Good Pharmacovigilance Process.

The proper basis for the science of pharmacoepidemiology (both descriptive and analytical) is to obtain signals for hypothesis testing. These are identified through the active use of pharmacovigilance – and especially the evaluation of spontaneously reported adverse drug reactions – accomplished by the efficient and effective application of best practices under a GPVP.

In the late 1990’s, Dr. Robert C. Nelson led the process re-engineering of the postmarketing surveillance program for human drugs at the U.S. Food and Drug Administration (FDA), which included the design and development of the Adverse Event Reporting System (AERS). That re-engineering effort also included a comprehensive and revised regulation rewrite, broad organizational and process modifications, and the launch of the risk management strategic framework.

Upon his retirement from the U.S. Public Health Service and the FDA in 1998, Dr. Nelson founded RCN Associates, Inc., as a consultancy to the pharmaceutical industry in the broad area of drug safety. Visit www.rcnrx.com for a description of the full range of service offerings. Recognizing that almost all of the companies he visited had inadequately prepared post-approval drug safety programs; one of his major focuses was to establish a GPVP in industry.

Seeing both rigorous processes and IT support as an “Achilles’ heel of these companies, he set out to find the best available systems – and found none to recommend. Therefore, as he did with FDA’s AERS, he designed and developed the best of breed.

RCN Associates, Inc. will consult on process development and good pharmacovigilance practices, so that Argus-PV can be used with maximal effectiveness.

(1) Nelson RC, Pederson D, D’Souza T. The US-FDA AERS Project. In Electronic Communication Technologies, Mitchard M (ed). Interpharm Press, 1998:497-51

(2) Bright RA, Nelson RC. Automated support for pharmacovigilance: a proposed system. Pharmacoepidemiology and Drug Safety 2002; 11:121-125

(3) Nelson RC, Palsulich P, Gogolak V. Good Pharmacovigilance Practices, Technology Enabled. Drug Safety 2002; 25(6): 407-414

For More Information Contact:

RCN Associates Inc.
36 East Lake Drive Suite 200 Annapolis, MD 21403 USA
Tel: 410-263-3355
FAX: 410-263-3932
Internet: rcnelson@rcnrx.com

RCN Associates, Inc. announces its direct and collaborative efforts in support of a Good Pharmacovigilance Process (GPVP).

Last modified: 11/21/03