sas_for_patient_safety_brochure
PRODUCT BRIEF
SAS? Patient Safety
Comprehensive safety reporting and signal detection
Overview Array Regulatory authorities, patients, health-
care professionals, government officials
and the media are increasing their scru-
tiny of drug safety based on continuing,
high-profile patient safety issues. Now
more than ever, healthcare profession-
als and patients must continuously
evaluate risks against benefits when
making decisions about the right
therapy. In this high-risk environment,
how can a company ensure it can
comprehensively assess the safety of
its therapies? A more comprehensive
safety profile provides more informed
risk-versus-benefit decisions.
SAS takes you beyond simple adverse
event reporting systems and unmanaged
signal detection to provide a compre-
hensive solution that addresses new
regulatory safety guidance and provides
the most advanced analytics for signal
detection and pharmacovigilance.
Ensure patient safety through proactive pharmacovigilance
Why SAS??
Simple analytics are appropriate for
certain tasks. However, the complexity
of patient safety demands the applica-
tion of the industry’s premier analytics
platform. SAS Patient Safety is the only
solution that combines safety reporting
capability with the most advanced
analytics available for signal detection
and pharmacovigilance. And the
breadth and depth of the underlying
SAS architecture makes SAS Patient
Safety a powerful ally to help you fully
understand the safety profile of your
therapies.
SAS Patient Safety includes all the
standard reports outlined in the FDA
Good Review Practices, plus a signal
detection and analysis accelerator
that includes the following advanced
analytical methods:
? PRR – proportional reporting ratio.
? ROR – reporting odds ratio.
? MGPS-EBGM – multigamma
Poisson shrinker – empirical Bayes
geometric mean.
? BCPNN-IC – Bayesian confidence
propagation neural network – infor-
mation component.
? ARS – Adjusted residual score.
Benefits
? Standard safety analyses reduce
programming and validation effort
As regulatory safety reporting
requirements continue to evolve, the
ability to efficiently document patient
safety through standard reports and
analyses is critical. SAS Patient Safety
provides standard safety analyses
that address new FDA safety guid-
ance and leverage CDISC implemen-
tations to produce standard reports.
The result is standard safety report-
ing with the flexibility to quickly adapt
to changing regulations.
? More informed drug development
decisions
A comprehensive approach to
pre-approval safety review can drive
better drug development decisions
and mitigate potential post-marketing
risks. SAS Patient Safety uses the
industry’s most advanced analytics
to facilitate the identification of true
pre-approval safety signals. Medical
evaluation of these signals may
identify safety concerns that are
critical for making informed drug
development program decisions.
Comprehensive pre-approval safety review also mitigates the risk of late-stage development failures due to safety issues and allows the develop-ment of a complete safety profile for your compound.
? Efficient PSUR submission
All research companies must periodi-cally summarize and report patient exposure and safety information
to the FDA in the form of a Periodic Safety Update Report (PSUR). SAS Patient Safety provides the capability to efficiently and compre-hensively produce the PSUR. ?Achieve the highest level of post-approval safety review
Once marketing approval has been obtained, accurate safety signal iden-tification and evaluation is critical to the welfare of your patients and to the success of your company. SAS Patient Safety leverages the indus-try’s most advanced analytics to implement a standard set of signal detection algorithms. Implementing
a proactive approach to emerging postmarket safety concerns can protect shareholder value, minimize potential negative media publicity, mitigate the loss of public trust and limit exposure to lawsuits.
? Rapid response to inquiries and media events
When faced with safety inquiries from regulatory authorities or members
of the media, you can rapidly and effectively respond with the most complete scientific information avail-able in order to minimize revenue erosion, protect shareholder value and maintain public trust.
About SAS
SAS is the leader in business intelligence and analytical software and services. Customers at 44,000 sites use SAS software to improve performance through insight from data, resulting in faster, more accurate business decisions; more profitable relationships with customers and suppliers; compliance with governmental regula-tions; research breakthroughs; and better products and processes. Only SAS offers leading data integration, storage, analytics and business intelligence applications within a comprehensive enterprise intelligence platform. Since 1976, SAS has been giving customers around the world THE POWER TO KNOW?.
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