Accenture provides end-to-end pharmacovigilance services from proof of concept to ongoing partnerships. This includes pharmacovigilance strategy, operations, technology, and consulting services. Accenture has experience implementing safety databases and processing over 1.5 million cases annually across multiple languages. They are also developing new technologies like INTIENT Pharmacovigilance Platform to accelerate industry goals through applied intelligence and automation.

1. Accelerating safety
solutions and insights
PHARMACO
VIGILANCE
SERVICES
Copyright © 2019 Accenture. All rights reserved.

2. Wesupporttheentire
Pharmacovigilance
Journey
FROMPROOFOFCONCEPTTO
END-TO-ENDSERVICES
PROOF OF CONCEPT
Demonstrate platform
capabilities and provide
evidence of efficiency
using B-R frameworks and
Safety Signal Detection –
a subset of cases.
INDUSTRIALIZE / ADOPT
the new methods for B-R
and Signal Detection.
CREATE & EXECUTE A
PHARMACOVIGILANCE
ANALYTICS ROADMAP
for the remaining use
cases’ industrialization
and adoption.
IMPLEMENT
PHARMACOVIGILANCE
ANALYTICS
ENVIRONMENT
capitalizing upon Proof of
Concept experience and
insight.
ESTABLISH ONGOING
PARTNERSHIP for
Pharmacovigilance
Analytics services.
START
NEXT
Copyright © 2019 Accenture. All rights reserved.

3. Copyright © 2019 Accenture. All rights reserved.
SYSTEM INTEGRATION &
IMPLEMENTATION
• Argus Global
Implementation
• Argus J Implementation
• Argus Application
Maintenance
• Argus Implementation on
Cloud
• Development and
maintenance of Custom
Safety Reports
PV CONSULTING
• Scope and Seek Work
• PV IT Roadmap
Development
• Process Optimization and
Change Management
• Operating Model Design
• PV Analytics Platform
• AE EDC and Workflow
Solutions
We have successfully
delivered seven major
safety database
implementation/
upgrade programs
in the industry with high-
quality and timely
execution in realizing an
advanced safety case
processing capability.

4. Copyright © 2019 Accenture. All rights reserved.
1,200
dedicated
Pharmacovigilance
resources including 60
Physicians
& 45 Medical Writers
350
audits and Inspections
without any
critical findings
14
languages supported
including Japanese
& Mandarin
1.5M
cases processed
annually
FIRST
global Argus
implementations
in the industry
300,000
literature abstracts
screened for
Adverse Events
and Signals
FIRST
to deliver Japanese-
language AE processing
from China
18
SESSIONS
of the Pharmacovigilance
Industry Leaders’
Roundtable

5. • PV Strategy & Transformation
• PV Operating Model Design &
Implementation
• PV Process Optimization
• PV Benefit-Risk Management
• PV Industry Leaders’ Roundtable
CONSULTING
Pharmacovigilance
Copyright © 2019 Accenture. All rights reserved.

6. • Adverse Event Case Intake
• Adverse Event Case Processing
• Global Multi-lingual Capabilities
• Aggregate Reporting
• Safety Surveillance
• Literature Screening
• Compliance Management
• Technology-enabled Operations
OPERATIONS
Copyright © 2019 Accenture. All rights reserved.
Pharmacovigilance

7. • Oracle Argus Platform
Implementation & Integration
• Oracle Argus Upgrade Factory
• PV Application Management Services
• Accenture Life Sciences Cloud for
Safety
• Digital PV Intake & Intelligent
Automation
• Advanced Safety Reporting, Analytics
& Insights
TECHNOLOGY
Copyright © 2019 Accenture. All rights reserved.
Pharmacovigilance

8. Copyright © 2019 Accenture. All rights reserved.
TM
INTIENT.
Pharmacovigilance
Accelerates industry goals
for eliminating manual
effort in case processing

9. INTIENT
Pharmacovigilance
Platform
CLOUD-BASED PLATFORM
Powered by Applied Intelligence, incorporating
artificial intelligence, natural language processing,
optical character recognition, machine learning and
machine translation.
DATA EXTRACTION
Extract case data from structured an unstructured
sources, and assesses the priority, seriousness,
expectedness and causality based on cognitive
inference and with a confidence score for each field.
ADVANCED SAFETY ANALYTICS
Offers advanced safety analytics for deriving
improved insights from combined internal and
external sources, with greater accuracy and new
visualizations to make much better and more timely
safety interventions.
MACHINE PRE-PROCESSING
Machine pre-processing of all types of machine-
readable source documents to generate well-formed
and high quality E2B output for import into an
enterprise safety system.
RE-INVENTING TEAMS
Re-invents the role of case handling teams from
processing cases to managing exceptions, allowing
companies to focus effort, energy and talent on
strategic activities to help improve patient safety
outcomes.
READY FOR IMPLEMENTATION
Our Pharmacovigilance platform is currently on third
GA release governed by the same validated system
development lifecycle as the established Clinical
platform, and is therefore ready for implementation
now.
Copyright © 2019 Accenture. All rights reserved.
TM

10. Learn more:
accenture.com/Pharmacovigilance
Copyright © 2019 Accenture. All rights reserved.
Grishma Sharma
Managing Director,
Global Pharmacovigilance
Practice Lead
grishma.sharma@accenture.com
April Davis
Industry Principal Director,
INTIENT Pharmacovigilance
Platform Lead
april.davis@accenture.com
Ross Wooddisse
Managing Director,
Global Pharmacovigilance
Strategy and Consulting Lead
ross.a.wooddisse@accenture.com