Insights on drug safety. Faster.

Faster insights about a product’s safety profile can lead to faster actions. i3 Aperio® is a first-in-class signal detection and assessment tool that leverages i3 Drug Safety’s epidemiological expertise and one of the largest post-launch sample populations to date—our proprietary claims database, which contains the de-identified health care experiences of millions of individuals—so that users can monitor the safety of new drugs quickly and effectively.

The US Food and Drug Administration (FDA) and the i3 Drug Safety epidemiology team are working together to monitor the safety of new drugs using i3 Aperio.

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 real-world environment
  • Continually improve the post-marketing surveillance of newly approved drugs
  • Monitor usage patterns and prescribing to patients with contraindications as an integral component of the risk management plan
  • Support research and development decision making
  • Put safety signals into a comparative context and permit the exploration of new patterns

Earlier detection of significant trends

Time is of the essence in responding to safety signals, and by using i3 Aperio, evidence-based responses can often be developed in days—cost-effectively. When signals arise from Phase IV trials or spontaneous reports, 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 challenge the validity of the signal rather than continuing to collect spontaneous reports and assess signal strength as new reports accumulate.

Essential to therapeutic decision making

By accelerating the acquisition of real-world information on new prescription drugs, i3 Aperio can help researchers identify signals that could indicate a drug’s potential safety issues in near-real time. Additionally, i3 Aperio data can ascertain the absence of safety issues, and provide reassurance by helping to quantify the prevalence of already-known effects—a capability essential to therapeutic decision making.