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INTIENT
Accenture Life Sciences
PHARMACOVIGILANCE
TM
Provides Earlier Insights, Better Data Transparency,
Improved Accuracy and Consistency
PHARMACOVIGILANCE IMPERATIVES
FOR THE PHARMA INDUSTRY
EFFECTIVE &
EFFICIENT
OPERATIONS
INCREASED FOCUS:
SAFETY, SCIENCE &
INSIGHT
INCREASED
VALUE FOR KEY
STAKEHOLDERS
Copyright 2020 Accenture. All rights reserved. 2
• 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
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
Copyright 2020 Accenture. All rights reserved. 3
INTIENT
Pharmacovigilance
Copyright 2020 Accenture. All rights reserved. 4
• 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
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
Copyright 2020 Accenture. All rights reserved. 5
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
• 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
Copyright 2020 Accenture. All rights reserved. 6
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
Copyright 2020 Accenture. All rights reserved. 7
APPLIED INTELLIGENCE
ACCENTURE +
IN PHARMACOVIGILANCE
Copyright 2020 Accenture. All rights reserved. 8
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
Copyright 2020 Accenture. All rights reserved. 9
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
Copyright 2020 Accenture. All rights reserved. 10
KEY SERVICES
PROVISIONED WITH
IMPLEMENTATION
SAFETY DATABASE
& MAINTENENCE
Copyright 2020 Accenture. All rights reserved. 11
• 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
Copyright 2020 Accenture. All rights reserved. 12
QUESTIONS?
APRIL DAVIS
Industry Principal Director
Life Sciences, Pharmacovigilance
april.davis@accenture.com
Copyright 2020 Accenture. All rights reserved. 13
Learn more: Accenture.com/INTIENTPharmacovigilance

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INTIENT Pharmacovigilance

  • 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 Copyright 2020 Accenture. All rights reserved. 2 • 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 Copyright 2020 Accenture. All rights reserved. 3
  • 4. INTIENT Pharmacovigilance Copyright 2020 Accenture. All rights reserved. 4 • 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 Copyright 2020 Accenture. All rights reserved. 5 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 Copyright 2020 Accenture. All rights reserved. 6
  • 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 Copyright 2020 Accenture. All rights reserved. 7
  • 8. APPLIED INTELLIGENCE ACCENTURE + IN PHARMACOVIGILANCE Copyright 2020 Accenture. All rights reserved. 8
  • 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 Copyright 2020 Accenture. All rights reserved. 9
  • 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 Copyright 2020 Accenture. All rights reserved. 10
  • 11. KEY SERVICES PROVISIONED WITH IMPLEMENTATION SAFETY DATABASE & MAINTENENCE Copyright 2020 Accenture. All rights reserved. 11
  • 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 Copyright 2020 Accenture. All rights reserved. 12
  • 13. QUESTIONS? APRIL DAVIS Industry Principal Director Life Sciences, Pharmacovigilance april.davis@accenture.com Copyright 2020 Accenture. All rights reserved. 13 Learn more: Accenture.com/INTIENTPharmacovigilance