FAERS Business Intelligence System (FBIS)
The FDA Adverse Event Reporting System (FAERS), which is a
database that contains information on adverse event and medication
error reports submitted to FDA which is designed to support the
FDA's post-marketing safety surveillance program for drug and
therapeutic biologic products. The health informatics structure of
the FAERS database adheres to the international safety reporting
guidance issued by the International Conference on Harmonization
Designed and developed the solution for Center for Drug
Evaluation and Research’s (CDER) Office of Surveillance and
Epidemiology (OSE) to detect, evaluate, and act upon adverse effects
reported to FDA proactively and ability to analyze and perform data
mining on various dimensions e.g. Designated Medical Events,
Medication Error, Adverse Event, Drug and Active Ingredient to
detect a pattern.
FBIS a fully-integrated suite of analytics tool launched since
2012 that provides charts, reports and ad-hoc query capability on
over nine million reports of adverse events and reflects data from
1969 to the present. Some key features of FBIS below:
Designated Alert Screening Reports (DASR) and Medication
Error Screening Reports (MESR) for detecting signals of serious risk
which is critical for FDA’s safety evaluators to monitor and enforce
post-market drug safety.
Critical alert reports delivered to safety evaluator’s
on-time for mandatory evaluation as per regulations and helped
improve critical drug safety for FDA.
Integrated adverse events and medication data to terms in
the Medical Dictionary for Regulatory Activities (MedDRA) and
provided capability for safety evaluators to slice and dice data
using MEDRA hierarchy.
Quick Query to perform multi-dimensional analysis on fixed
set of 50 dimensions e.g. products, active ingredients, drugs, lots
etc. and drill down to reported adverse event and view the associate
Reporting by health care providers, consumers, patient
outcome presented as scheduled reports, canned reports, personalized
query and ad-query.
Data extracted from FAERS systems daily, transformed and
aggregated for optimal performance.
Number of Users: 300+
Number of Adverse Events
Stored: Over 9m
Deployed In: Enterprise wide in
External Interfaces: FAER
Canned Reports: 200+ reports
with role based data restrictions
Other Features: Ad-Hoc Query,
Email Notification, personalized scheduling of reports
Technology: SAP Business
Objects, Oracle Data Warehouse, Informatica