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New tool will help pharmaceutical companies and regulators monitor prescription drug performance; Drug Registry will provide faster access to data to assess drug safety
BASKING RIDGE, NJ (April 28, 2005) - As the scientific community continues to develop tools to cure disease and improve the quality of life, there is increasing demand for more effective means to evaluate pharmaceutical safety. In response to this need, i3, the research services business of healthcare informatics leader Ingenix, is introducing i3 Aperio, an advanced drug registry tool that will allow drug manufacturers and regulators to access data on the safety of newly introduced drugs faster and more efficiently than ever before. This new drug registry will pair i3's technology and scientific expertise with the Ingenix database of de-identified health care experience and will provide faster access to data that can help researchers assess the relative risks of newly introduced drugs.
The i3 Aperio drug registry will be a resource that pharmaceutical companies, regulatory agencies such as the U.S. Food and Drug Administration (FDA), and other stakeholders can use to evaluate newly introduced prescription drugs in a timely and objective manner. In addition the results of analysis performed by pharmaceutical companies and regulators may ultimately help physicians write prescriptions with greater confidence, and allow patients to take new medications with added comfort and security.
"i3's innovative approach and access to the large and growing databases of Ingenix will provide pharmaceutical manufacturers with critical information allowing them to make swift safety determinations at a speed that could not have been achieved with current methodologies," said Donato Tramuto, CEO of i3.
How i3 Aperio will work
Through its parent company, Ingenix, i3 has access to longitudinal and integrated prescription, laboratory, and general medical experience from well over 10 million individuals. Consistent with HIPAA regulations, records are de-identified to protect the privacy of individuals.
Due to the large number of experiences that are reflected in the database, even a drug prescribed in moderate volume will likely be reflected in enough data to perform meaningful analysis.
The resulting drug registry information will be available in two formats: quarterly, Web-based files suitable for manipulation and analysis by informed users, as well as an annual report of static data. i3 Aperio files and reports are not intended, and will not be available, for consumer use as they will require an understanding of the data and skill in interpretation that is not available to the casual user.
Commenting on the tool, i3 Senior Scientist, K. Arnold Chan, MD, ScD noted, "Clinical trials are a powerful and essential step in testing drug safety, but by necessity, they are generally performed on limited numbers of people who don't have other diseases or take other medications. i3 Aperio offers researchers the data to analyze real-world prescription drug experience, including the health experiences of patients with co-morbidities, or those taking multiple medications. Further, the registry will provide a much greater scope of data, which may allow researchers to identify more rare side effects that did not surface in prior analysis."
"i3 Aperio will add a proactive tool to the current system and help accelerate the detection of critical safety issues," said Tramuto. "This product will assist the pharmaceutical industry and regulators in their efforts to assess the safety of drugs and improve public health."
In addition to providing particular data to help assess safety concerns, i3 Aperio will offer an annual report of all drugs in the registry. Manufacturers may opt for more detailed information about how their drug is being used in the marketplace.
i3 plans to make i3 Aperio available by the third quarter of 2005. More information is available at www.i3Aperio.com.
i3, a global Ingenix business, provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle. It comprises: i3 Research, a therapeutically specialized contract research organization; i3 Statprobe, a leader in comprehensive data services; i3 Pharma Resourcing, a world-class staffing partner; and i3 Magnifi, delivering the science and solutions to achieve marketplace success. i3 helps companies gain sharper insights that lead to better patient care. For more information, visit www.i3global.com.
One of the industry's leading health information companies, Ingenix provides products and services to a diverse customer base within the health care community. Organizations rely on our innovative technology to improve the delivery and operations of their business. For additional information about Ingenix and its products and services visit www.ingenix.com. Ingenix is a wholly owned subsidiary of UnitedHealth Group (NYSE:UNH).