ARIS GLOBAL RELEASES SAFETY MART V2.2- SOFTWARE FOR THE ANALYSIS OF SAFETY DATA

Applied Clinical Trials

ArisGlobal, a leading provider of pharmacovigilance software solutions, announces the general availability of SafetyMart, a comprehensive data mining and signal detection application which facilitates in-depth data analysis and proactive benefit/risk assessment of drug safety data.

STAMFORD, CT and MILTON KEYNES, UK – January 12, 2006 – ArisGlobal, a leading provider of pharmacovigilance software solutions, announces the general availability of SafetyMart, a comprehensive data mining and signal detection application which facilitates in-depth data analysis and proactive benefit/risk assessment of drug safety data. Due to increased safety concerns, drug manufacturers are coming under closer scrutiny by both government and consumers. In Europe, Regulation 726/2004/EC which went into effect on November 20, 2005 impacts life science companies' pharmacovigilance and risk management practices. Volume 9a, currently in draft, also extensively describes the requirements for Risk Management Systems.

In the US, the FDA has recently published guidelines for the development and use of Risk Minimization Action Plans (RiskMAPS). These regulations, plus a host of other guidelines make it essential for life science companies to implement effective risk management practices and strategies.

According to the FDA Guidance for Industry Good Pharmacovigilance Practices & Pharmacoepidemiological Assessment, March 2005, "Postmarketing safety data collection and risk assessment are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization."

Utilizing sophisticated data mining techniques, SafetyMart reduces the time required to analyze company data allowing users to perform drill-down analysis and test hypothesis. With SafetyMart, users can also easily generate ad-hoc queries, create reports and write summary ASRs and PSURs – enabling organizations to respond faster in the event of a regulatory inquiry.

Optionally, SafetyMart is also provided with the FDA (FOI) data. As such, life science companies can appraise their products' performance through the eyes of the FDA, evaluate the safety behavior of similar compounds, assess the performance activities of competitive drugs and gain a better understanding of emerging patterns and trends.

Other business benefits of SafetyMart 2.2

  • Rapidly assess data quality and identifies cases needing revision
  • Responds quickly to regulatory challenges
  • Increases safety system performance by offloading analysis and reporting
  • Minimizes uncertainty surrounding the safety performance of products

About the Company

ArisGlobal LLC is a leading provider of Pharmacovigilance and Safety, Registration Information Management, Clinical Trials Management and Medical Communications software solutions to the pharmaceutical, biotechnology, medical device and clinical research organization (CRO) markets. ArisGlobal software solutions are being used by over 100 life science companies including major pharmaceutical companies across the world. ArisGlobal software helps companies meet international regulatory requirements, manage risk, improve operational efficiencies and easily share mission-critical information on a global basis.