Life Sciences companies are challenged by the increasing amount of information that needs to be collected, managed and analyzed during pre- and post-approval safety monitoring. Learn more about Pega solutions for Life Sciences: http://www.pega.com/solutions/by-industry/life-sciences

1. Pega’s approach can and will improve agility by reducing duplicate efforts, increasing
compliance, improving data visibility, driving costs out of the safety process, and
speeding time to market, resulting in faster time to revenue and higher margins
OUR APPROACH
FOR MORE INFORMATION ON PEGA’S LIFE SCIENCE SOLUTIONS, VISIT WWW.PEGA.COM/LIFESCIENCE
Our approach to Adverse Event transformation can and will improve agility by reducing duplicate efforts, increasing compliance, improving
data visibility, driving costs out of the safety process, and speeding time to market, resulting in faster time to revenue and higher margins.
INTEGRATION BUSINESS
RULES
CASE
MANAGEMENT
PARALLEL
WORKFLOWS
BETTER USE
OF RESOURCES
Get better information
earlier in the AE reporting
process by pushing
regulatory questions into
CRM and other systems
Improve the application
of regulatory reporting
rules for deciding what
needs to be reported and
to which regulators
Simultaneously support
multiple product types
(e.g. drugs & devices),
deadlines, and reports in
a single case
Improve case handling to
support parallel processes
and multiple classifications
– specialize case handling
to run multiple tasks in
parallel
Take advantage of
skill-based routing
of cases to mange multiple
languages, regulator, and
product specialties
Pega PV is designed to manage adverse events, risk and regulatory reporting obligations across
products and jurisdictions globally.
THE SOLUTION
LOWER
COSTS BY
40-50%
PRODUCTIVITY
GAINS
REDUCED
PAPERWORK
REDUCED
EFFORT
& COST
REDUCED MANUAL
INTERVENTION
LACK OF OPTIMIZED SYSTEMS
AND RESOURCES
resulting in duplicative efforts
SAFETY REPORTING
REQUIREMENTS VARY
by region, product, IRB/IEC
governance
INCREASED AWARENESS
among patients and consumers of
the importance of reporting AEs
REGULATORS ARE
MORE RISK ADVERSE
resulting in more stringent
requirements for the consolidation
and reporting of safety data
INCREASING REGULATORY
COMPLIANCE AND
ADMINISTRATIVE COSTS
PHARMACOVIGILANCE REPRESENTS
A SIGNIFICANT OPPORTUNITY, BUT
EXISTING PROCESSES AND
SOLUTIONS AREN’T KEEPING UP
WITH DELIVERING AND MANAGING
A HOLISTIC APPROACH.
INTAKE
Improve data capture and
triage with dynamic
questionnaires that
automatically customize
for a specific product type,
region, and safety profile
With Pega’s solution, companies are able to
automate all phases of Adverse Event management
and Safety processing.
THE BENEFITS
Life Sciences companies are able to provide opportunity
for unprecedented process innovation, reducing the overall
cost and timeline for conducting successful clinical trials.
THE RESULTS
Life Sciences companies are challenged by the increasing amount of information that needs to be
collected, managed and analyzed during pre- and post-approval safety monitoring.
THE CHALLENGES
MINIMAL
SYSTEM
DOWNTIME
Business users easily
create and manage
intent-driven processes
CUSTOMIZED
INTERFACES AND
WORKFLOWS
for safety reporting
REDUCES COMMON
DUPLICATE EFFORTS
for processing Adverse
Event cases
Premarket and postmarked
reporting requirements
SHARE THE NEWS!
PHARMACOVIGILANCE
(DRUG SAFETY)
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About Pegasystems
Pegasystems revolutionizes how leading organizations optimize customer experience and automate operations. Seven of the 10 largest global insurance companies use Pega technology to deliver an exceptional customer
experience, improve retention rates and maximize customer lifetime value. Our patented Build for Change®
technology empowers business people to create and evolve their critical business systems. Pegasystems is the
recognized leader in business process management and is also ranked as a leader in customer relationship management software by leading industry analysts. For more information, please visit us at www.pega.com.