A product suite that collects, manages and learns from the full spectrum of pharmacovigilance data. Visit https://accntu.re/2vTyhY5 to learn more.

1. INTIENT
Accenture Life Sciences
PHARMACOVIGILANCE
TM
Provides Earlier Insights, Better Data Transparency,
Improved Accuracy and Consistency

2. PHARMACOVIGILANCE IMPERATIVES
FOR THE PHARMA INDUSTRY
EFFECTIVE &
EFFICIENT
OPERATIONS
INCREASED FOCUS:
SAFETY, SCIENCE &
INSIGHT
INCREASED
VALUE FOR KEY
STAKEHOLDERS
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• Highly efficient
quality case
processing
• Better Patient
Support Programs
• More informed HA
interactions, better
“brand” for Safety
and Patients
• Better evaluation of
detected signals
• External signals
validation (get a better
view of benefit-risk)
• New data sources, tools
and technologies
• Innovative ways of
visualizing data and
gleaning insights using
AI/ ML
• More informed product
and program design
• More informed labels
and PV Regulatory
Coordination
• Networked with
healthcare
practitioners
• Supporting safety
literacy across the
ecosystem

3. INTIENT Pharmacovigilance helps life sciences
companies accelerate processes and the generation of
critical insights—insights that can help companies
uncover patient safety impacts from existing products
and better manage the risks of new products, as well as
respond to new stakeholder demands across the
healthcare landscape.
INTIENT
Pharmacovigilance
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4. INTIENT
Pharmacovigilance
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• Delivers a centralized environment to collect, manage and
learn from the entire spectrum of patient safety data
• Embeds real-time artificial intelligence, machine learning,
robotic process automation and advanced operational and
scientific analytics in each step of the pharmacovigilance
process—from patient data source and case intake to
regulatory reporting and distribution
• Provides earlier insights, better data transparency, improved
accuracy and consistency in reporting, and more timely
discovery of potential adverse events

5. DISRUPTING
THE NORMAL
PROCESS FOR
CASE INTAKE &
PROCESSING …
THE OLD MANUAL WAY
CASE
INTAKE/
DATA
ENTRY
ROUTE TO
CASE
PROCESS-
ING
CASE
PROCESS-
ING
ROUTE TO
QUALITY
REVIEW
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Email, Fax,
Paper, Batch
Duplicate
check
Identify
seriousness
Prioritize
case (Day0)
Split cases
(multiple
patients)
Link cases
Complete the
data entry of
all case details
Use of IME
and Drug lists
Medical
history
Generate
narrative
and modify
Identify
missing and
incorrect info
Request
follow up

6. • Automated Case
Intake
• Case Processing
• Using AI, ML,
NLP, OCR
XML export to
Safety System
for case
completion
• Exception
Handling UI
• Review
corrections and
acceptance
ML FEEDBACK LOOP
…BYRADICALLY
AUTOMATINGTO
MAKEITPARALLEL,
ACCURATE,
CONSISTENT,
FOCUSEDAND
HIGHLYEFFICIENT.
THE NEW WAY
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7. Powered by Applied Intelligence,
incorporates artificial intelligence,
robotic process automation, natural
language processing, optical character
recognition, machine learning and
machine translation
INTIENT
Pharmacovigilance
Enables 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 such as Argus Safety
Extracts case data from structured and
unstructured sources, and assesses the
priority, seriousness, expectedness and
causality based on cognitive inference
and with a confidence score for each field
Delivers proven technology, as the
platform is currently on its third GA release
and is governed by a validated system
development lifecycle, and is therefore
ready for implementation now
INTEGRATION
SERVICES
ANALYTICS
APPLICATIONS
DATA
INFRASTRUCTURE
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
Offers advanced safety analytics for
deriving improved insights from combined
internal and external sources, with greater
accuracy and new visualisations to make
more better and more timely safety
interventions
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8. APPLIED INTELLIGENCE
ACCENTURE +
IN PHARMACOVIGILANCE
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9. INTIENT PV –
GENERATION 0
• Text Analytics with Literature
• Automating drug safety
analysis with Natural
Language Processing
INTIENTPV–
DESIGNPHASE
GENERATION1.0
• Modular, Scalable Platform
Approach
• User Experience Critical for
Success
• Technology Enabled
Operations
INTIENT PV –
RPA BOTS LIVE
• Book In and Email Use Cases
• Accenture First in Industry
• First in R&D with RPA
INTIENT PV V1.0 –
MARKET RELEASE
• POCs and Pilots with 2 Tier 1
biopharma
• Focus on Literature Entity
Extraction, NLP, and OCR
INTIENT PV V2.2 –
PRODUCTION USE AT CLIENT
• Integrated with Argus
• Unstructured & Structured Forms
• Tech Enabled Ops Business Case
INTIENT PV –
EXPANSION
• Convergence with AIHC
• Re-use of micro services and
analytics / insights
2015 2016 2017 2018 2019 NEXT
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10. WE SUPPORT THE ENTIRE
PHARMACOVIGILANCE
JOURNEY
From Proof Of Concept
to End-to-end Services
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 PV
ANALYTICS ROADMAP
for the remaining use
cases’ industrialization
and adoption
IMPLEMENT PV
ANALYTICS
ENVIRONMENT
capitalizing upon proof-
of-concept experience
and insight
ESTABLISH ONGOING
PARTNERSHIP for PV
Analytics services
START
NEXT
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11. KEY SERVICES
PROVISIONED WITH
IMPLEMENTATION
SAFETY DATABASE
& MAINTENENCE
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12. • Argus Global Implementation
• Argus J Implementation
• Argus Application
Maintenance
• Argus Implementation on
Cloud
• Development and
maintenance of Custom
Safety Reports
SYSTEM INTEGRATION
& IMPLEMENTATION
We have successfully
delivered seven major
safety database
implementation/
upgrade programs in the
life sciences industry,
with high-quality and
timely execution in
realizing an advanced
safety case processing
capability.
• Scope and Seek Work
• PV IT Roadmap Development
• Process Optimization and
Change Management
• Operating Model Design
• PV Analytics Platform
• AE EDC and Workflow
Solutions
PV
CONSULTING
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13. QUESTIONS?
APRIL DAVIS
Industry Principal Director
Life Sciences, Pharmacovigilance
april.davis@accenture.com
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Learn more: Accenture.com/INTIENTPharmacovigilance