Learn More: http://ap.pn/2kuWL2V The demands on Pharmacovigilance (PV) organizations are increasing as health authorities seek to reduce exposure to medications where risk outweighs benefit. Learn more how an application platform can: - Eliminate manual processes by automating adverse event case management and reporting - Reduce costs and time from signal detection to adjudication and labeling changes - Accelerate the right decision with built-in mobile and social collaboration technologies - Increase visibility with complete records of all pharmacovigilance elements from across systems Learn More: http://ap.pn/2kuWL2V

1. Pharmacovigilance
Pressures Demand
Transformative Technology

2. Introduction
The demands on Pharmacovigilance (PV)
organizations are increasing as health
authorities seek to reduce exposure to
medications where risk outweighs benefit.
Commercial life science companies are
confronted daily with multiple inputs that
require analysis and response to minimize
risks associated with approved medical
products.
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3. The Challenge
Clear information and rapid, collaborative input is
required to make appropriate decisions, but most PV
organizations cannot quickly get the necessary
information and input, putting companies at undue risk.
Heavily siloed data
Limited integrations
Inconsistent standards across geographic
boundaries and therapeutic categories
Unreliable and highly variable processes
Complex, non-harmonized global regulations
WHY?
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4. Too much manual effort and re-entry of data exists in
places where automation should reign:
Increase risk of errors
Lack transparency and insight into the process
Limit analytic capabilities
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Email becomes the default collaboration
tool, but rarely are all the right people
included in a given discussion.
Data required for regulatory reporting
purposes is generally maintained in
complicated excel spreadsheets.
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THESE APPROACHES:

5. The net result is PV professionals are
forced to work in inefficient, disjointed
ways and waste hundreds of hours trying
to complete basic tasks.

6. How PV Organizations
Should Function
IF THEY HAD THE RIGHT TECHNOLOGY:
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Managers have visibility to the full volume of
activity to quickly spot trends and raise alerts.
People who provide relevant information are
automatically made aware of situations where
they can contribute.
Issues that require reporting to the various
regulatory bodies are completed in the
format each regulator requires without a
huge manual effort.
Necessary labeling changes move through
the system with great speed.
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The costs of not having ideal collaboration
and fast-moving information are great:
PV staff inefficiency is extremely costly; most are
highly trained doctors and other professionals
with advanced degrees.
Safety signal information not handled
appropriately and not reported in a timely
manner exposes the organization to regulatory
fines.
Information received but not properly
researched or used exposes the company to
potential litigation.
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8. Effective technology that ensures proper
movement of information while maximizing
collaboration can make an enormous
difference.

9. The Appian Platform:
The New Backbone for Pharmacovigilance
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Appian is an application platform that allows organizations to create their own
process–and–data–based apps and integrate them with existing IT systems.
Appian has roots in Business Process Management (BPM) and has greatly
expanded those concepts to include:
Process–based
collaboration
Native mobile
access
Unified
records

10. Here are some of the specific ways using
The Appian Platform can positively impact
operations in your PV organization.

11. Rapid Signal Adjudication
and Reporting
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Dramatically reduce the time from signal detection
to characterization to adjudication.
Minimize manual activities, duplicate entries and
reduce risk of errors or inaccurate data through
process automation.
Automate the import of safety information coming
from multiple sources suitable for regulatory
reporting purposes
(PSUR, DSUR, etc).
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12. Automate PV Task Management
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Apps on The Appian Platform
can be created to eliminate
“white spaces” between existing
IT systems that PV teams use.
Appian provides complete
audit trails and automatic
software documentation to
mitigate organizational risk.
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13. Increase PV Activity Visibility
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Requires only a single report, viewable from any
mobile device
Provides executives any-time insight to identify
process inefficiencies and bottlenecks
Allow users to drill down through reports to see
more detail and be better informed on the spot
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A 360-degree view of all PV activity:

14. Enhance Collaboration
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Enable process steps to trigger notices to Appian’s
News feed so PV event and/or notice information
is automatically pushed to those who need it, all in
an intuitive, collaborative interface with no need
for email.
The same interface can be used to gather
knowledge and take direct action, speeding up
cycle times.
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15. Unif ed Records of Any
PV Element
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Information from multiple systems is converged
into a single unified record in the Appian interface,
greatly reducing the time and effort users need to
find valid, useful information.
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16. www.appian.com/blog
Learn More
The Appian Platform is uniquely positioned to provide the
technology solutions PV organizations need to stay ahead of
increasing demands and changing requirements.
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