Changing the Approach to Pharmacovigilance

i3 Aperio^® is a first-in-class medical product safety surveillance tool that leverages i3 Drug Safety’s epidemiological expertise and one of the largest post-launch sample populations to date—our proprietary integrated health care database, which contains de-identified medical and pharmacy data for over 25 million individuals—so that users can monitor the safety of new drugs quickly and effectively.

i3 Aperio offers:

• Wide variety of standard tables for New Molecular Entities (NMEs) and related comparators
• Quarterly updates with one-year follow-up
• Customization to meet your needs
• Custom comparators, multiple comparators
• User-defined outcomes
• Specialized reports
• Extended accrual or follow-up periods designed to meet regulatory requirements

Real-world data, real-world benefits

Data produced by i3 Aperio can enable users to:

• Track a new or existing drug’s safety profile in a natural environment
• Get insight into real-life utilization, including off label use
• Put safety signals into a comparative context using standard or custom comparators
• Monitor usage patterns and prescribing to patients with contraindications as an integral component of the risk management plan
• Obtain information on comparative effectiveness

Earlier detection of significant trends

i3 Aperio can help researchers assess signals in near-real time and do it cost-effectively.  When potential safety signals arise, i3 Aperio helps researchers quickly investigate them by providing a denominator to estimate rates as well as a comparison group against which these rates can be evaluated.

i3 Aperio offers a complementary approach to the status quo, enabling researchers to corroborate or question the validity of the signal in addition to continuing to collect spontaneous reports and assess signal strength as new reports accumulate. Clients include bio-pharmaceutical companies and regulatory authorities.