• Clinical Data Solutions
• Randomization and Trial Supply Management
• Phase I Clinic Automation
• Safety Solutions
  • Pre-Marketing Signal Detection
  • Post-Marketing Surveillance
  • Adverse Event Management
  • Lifecycle Safety Management
  • Healthcare Data Mining for Safety
• Clinical Development Center
• Late Phase and ePRO Solutions
• CDISC Standards

Pre-Marketing Signal Detection

Recent withdrawals of approved drugs have increased regulatory attention to evaluation of a drug’s safety profile prior to approval. Many advances have been made in the mining of post-marketing adverse event data in recent years. Clinical trial data has typically not been amenable to safety data mining techniques due to small sample sizes narrow variations in database designs. However, the high quality and completeness of clinical information available from trial databases make these sources particularly rich in information and the availability of data standards now makes it possible to use these databases more effectively for signal detection. The promise of gaining deeper knowledge from clinical trial databases is enormous.

Empirica™ Study

Built upon Phase Forward’s Lincoln Technologies WebSDM electronic data submission platform, which was developed in cooperation with the FDA, the Empirica Study system integrates data from clinical trials into a CDISC SDTM-compliant data repository and performs automated screening for potential safety issues. This revolutionary tool provides an effective means for detecting potential safety problems early in the pre-marketing clinical trial stage. Using Empirica Study, biopharmaceutical companies can improve their understanding of a drug’s safety profile earlier in the development cycle.

The Empirica Study product offers graphical, tabular and statistical tools to assist clinical safety staff in examining, analyzing and classifying potential signals prior to drug approval. The Sector Map graph pictured below highlights adverse event terms with higher than expected counts in red for patients treated with a study drug.

Events that occur with higher than expected frequency for a comparator or placebo group appear in green, helping reviewers prioritize investigational efforts. This Sector Map groups the events into MedDRA System Organ Classes (SOCs) denoted by the rectangles outlined in white.

This visualization allows the analysis of associated events in an easy-to-interpret graphical format. Users may click on the rectangles and drill down to view the patient data associated with each patient experiencing each adverse event for more detailed analysis.

The Empirica Study product includes a full range of other advanced graphical visualization tools to better understand the safety profile of products in development.