Research and Development Solutions | Accenture

accenture
SEE THE
PATIENT
INYOUR
PRODUCTS.
Accenture Life Sciences
Copyright © 2020 Accenture. All rights reserved. 2
WE HELP
OUR
CLIENTS
SOLVE
FOR
PATIENTS
Leverage data insights from
across the life sciences
ecosystem to transform how
therapies are developed and
patient care is delivered
Connect with our
combined life sciences
passion and expertise
to help you solve for
patients
Harness the
digitalization of R&D
and creatively apply
connected technology
solutions
Accenture Life Sciences
Our expertise in driving better outcomes for Life Sciences companies
LIFESCIENCES
INDUSTRYLEADERSHIP
Accenture Life Sciences
3Copyright © 2020 Accenture All rights reserved.
Leader In Digital
& Commercial
• Leader in all four IDC
MarketScape Worldwide Life
Sciences Sales and Marketing reports
(Strategy/Consulting,
BPO, IT, Digital)
• Leader in Everest Group 2019 PEAK
Matrix™ Life Sciences Digital
Services
• Ranked by Ad Age as the
Largest Digital Network Agency
in the world
Leader in IT
Application Services
• Ranked as Top IT Services Vendor in
Life Science Industry for five years in a
row by IDC Health Insights
• Positioned as Leader and Star
Performer in Everest Group
2017 Life Sciences IT Application
Services Assessment
• Leader position on Everest
Group’s PEAK Matrix™ for
European Life Sciences ITO
Leader in Real World
Evidence
• Received 2018 Frost & Sullivan
Market Leadership Award for Real-
World Evidence Enterprise
Solutions
Leader in Research
& Development
• Positioned as Top Leader in Everest
Group 2020 Life Sciences Operations
Services PEAK Matrix™ Assessment
• Positioned as Leader in Everest Group
2019 PEAK Matrix™ for Data &
Analytics Service Providers
• Positioned as Leader and Star
Performer in Everest Group 2017 Life
Sciences Clinical and R&D
IT Services Assessment
• Positioned as a Leader in IDC
MarketScape on Life Science Drug
Safety Services, ITO, BPO and
Strategic Consulting (2016, 2018)
Commercial Services
Research Clinical
Pharmaco-
vigilance
Regulatory
Access and
Launch
Patient
Services
Marketing
Services
Patient
Insight
Services
Intelligent Supply Chain
Enterprise Technology Services | Accenture INTIENT™ platform
4Copyright © 2020 Accenture. All rights reserved.
R&D Services
Accenture Life Sciences
Better Patient
and Economic
Outcomes
OURLIFESCIENCES
SOLUTIONS
Copyright © 2020 Accenture. All rights reserved. 5
ACLOSERLOOK:
R&D &PATIENTSERVICES
RESEARCH CLINICAL REGULATORY PV PATIENT
SERVICES
Accenture Life Sciences
ACCENTURE INTIENT™ PLATFORM POWERED BY GOOGLE
Accenture Life Sciences
RESEARCH&
SCIENTIFIC
INFORMATICS
Experience in major
lab informatics
solution categories,
including ELN,
CDMS, LIMS, SDMS
Multiple
Industry
Experience
Life sciences, consumer
products, oil and gas,
agrochemical,
government
25 years
of domain experience
and thought leadership
Global
delivery
capabilities
BUSINESS TRANSFORMATION
• Operating model assessment and design
• Operating model implementation
• Creation of new entities spanning
multiple commercial organizations
• Project and change management
• Business process harmonization
COMPLIANCE
• Validation services
• CFR 21 Part 11 compliance
MANAGED SERVICES
• Production application support
• Lab environment management
• Scientific data management
• Knowledge management
TECHNOLOGY
• INTIENT Research platform – custom
cloud migrations and projects
• Lab automation
• Enterprise lab informatics
system implementation
• Enterprise scientific data management
• Enterprise application integration
• Machine learning and
Artificial Intelligence planning
and implementation
CONSULTING
• Informatics/IT road-mapping & strategy
• Scientific partnership identification with
commercial and academic organizations
• Landscape evaluation from early
discovery through to quality labs
Scientific
Informatics
Center of
Excellence
75%
of team with
background
in chemistry, biology,
and other sciences
6Copyright © 2020 Accenture All rights reserved.
Accenture Life Sciences
CLINICAL
SERVICES
CONSULTING
• Digital Clinical Development Strategy
• Operating Model Design
and Implementation
• Process Optimization,
Change Management and
Clinical Sourcing Strategy
• Clinical Data Standards Strategy and
Governance
• Clinical Analytics Strategy
OPERATIONS
• Data Management: Medidata Rave,
Oracle Inform and Medrio
• Clinical Monitoring/Medical Writing
• Clinical Data Transparency
and Disclosure
• Programming and Statistics
MANAGED SERVICES
• Business, Information and
Technology Architecture
Enabling End-to-End Data Flow
• Investigator Payments
• Database Setup, Closeout and
Analysis including EDC Rave
Implementation, Process,
Integrations and Training
• Clinical Application
Management Services
• Clinical Data Asset Review
TECHNOLOGY
• INTIENT Clinical platform
• EDC and IRT Integration with CTMS, eTMF
and other internal systems
• Mhealth Technologies
7Copyright © 2020 Accenture All rights reserved.
1,350 clinical data
services experts globally
8,500+
ADaM datasets created
2,500+
EDC Study Builds
(35% InForm, 15% Rave)
1,500+
Databases Locked
4,635
clinical studies managed
1,200
studies mapped to SDTM
80+ SDTM-based
submissions to the FDA
100+ CDISC
submissions to the FDA
75,000+
TLFs Produced
6.5 million
clinical research case
report forms processed
14 TAs
supported
(Top 5 TAs: Immuno-
Oncology, Cardiovascular,
Respiratory, Vaccines,
Neuroscience)
Accenture Life Sciences
REGULATORY
SERVICES
8Copyright © 2020 Accenture All rights reserved.
4,000+
xEVMPD messages
(Sept. 2013 to-date)
200
skilled Regulatory
professionals
26+
therapeutic areas
Submissions experience in
106
markets in
over 90
countries
10,000+Health Authority
submissions in 2018
950+
Regulatory applications
maintained
20+
YEARS
of Regulatory
Operations Experience
CONSULTING
• Business / Process transformation
• Program management
• Regulatory compliance assessment and
remediation programs (CMC, Labelling)
• Change management
• Training strategy & execution
TECHNOLOGY
• Technology strategy road mapping
• IT transformation /
Veeva RIM implementation
• Regulatory automation engineering
• Labelling automation solution
• Authoring templates (StartingPoint)
OPERATIONS
• Regulatory strategy & advisory projects
• CMC & Labelling management
(incl. authoring, change coordination)
• Major & LCM submissions
management and production
– Planning & compilation
– Formatting & publishing
– Dispatch, archiving & tracking
Accenture Life Sciences
PHARMA-
COVIGILANCE
SERVICESCONSULTING
• PV Strategy & Transformation
• PV Operating Model Design
and Implementation
• PV ProcessOptimization
• PV Benefit Risk
and Risk Management
• PV Industry Leaders’ Roundtable
TECHNOLOGY
• INTIENT Pharmacovigilance platform
• Oracle Argus platform implementation
and integration
• Digital PV Solutions: Intake, Automation &
Advanced Analytics
• PV Application
Management Services
• Reporting and Analytics
• Argus Factory
OPERATIONS
• Adverse event case intake
(multi-lingual)
• Adverse event case processing (multi-
lingual)
• Aggregate reporting
• Safety surveillance
• Literature screening
• Compliant management
• Technology Enabled Operations
9Copyright © 2020 Accenture All rights reserved.
1st
pharma and CRO
Oracle Argus 8.x
implementation
programs in the
industry. Includes
eVAERs, eMDR, and
PMDA E2B integration.
10+ Bots
in Safety Operations
driving technology-
enabled operations
1,600
Dedicated PV resources
including 60 Physicians
and 45 Medical Writers
1.5 M+
Individual Case Safety
Reports processed annually
1st
to deliver Japanese-
language AE
processing from China
300,000
Literature abstracts
screened for Adverse
Events and Signals
Accenture Life Sciences
PATIENT
SERVICES
Global Delivery and
Innovation centers in
Barcelona,
Dublin, India
& the USA
Business services,
enabled by real-world
analytics and
proprietary
technology, to drive
measurable impact on
patient outcomes
450Experienced patient
services practitioners
globally
Offering expertise and
serving patients across
14
therapeutic areas
Engaged with
85%
Of the world’s top 25 life
sciences companies
Serving
15+million patients
In 19 countries
REAL-WORLD
OUTCOMES RESEARCH
PERSONALIZED
COMMERICAL EXECUTION
PATIENT ENGAGEMENT
SUPPORT
INTEGRATED
PATIENT CARE
• OUTCOME: Create greater
understanding of clinical and
economic value
• HOW: Drive deeper patient insight
for design of studies, services, digital
solutions, and commercial
agreements
• OUTCOME: Personalize experiences
& improve commercial effectiveness
• HOW: Bring novel data and insights
to inform campaign design, content,
and channels
• OUTCOME: Improve initiation and
compliance to prescribed treatment
• HOW: Activate the healthcare
community to increase awareness,
access, and adherence
• OUTCOME: Engage in patient care
to support better treatment
outcomes
• HOW: Enable coordinated patient
services, which provide improved
support for clinical care
10Copyright © 2020 Accenture All rights reserved.
• OUTCOME: Enable data and process
integration to ensure coordinated
delivery of care against critical
timelines
• HOW: Helps capture, store, import,
standardize and analyze volumes of
data for personalized patient
treatment delivery
PRECISION MEDICINE
DELIVERY
11
PLATFORMTECHNOLOGY
This new market reality is
demanding …
▪ New Data
▪ New Value Measures
▪ New Therapeutic Solutions
▪ New Business Strategies
▪ New Collaborations
▪ New Technologies
INTIENT
MOVINGFROMAMBITIONTOACTION
TM
Accenture Life Sciences
Copyright © 2020 Accenture. All rights reserved.
INTIENT
Applied
Intelligence
Data
Management
Secure
Infrastructure
Integrated
Applications
INTIENTNetwork
Enabling access to a partner ecosystem of digital innovation.
™
INTIENT
Patient
INTIENT
PV
INTIENT
Clinical
INTIENT
Research
POWERED BYGOOGLECLOUD
Copyright © 2020 Accenture. All rights reserved. 12
Safe & secure
Offers trusted and compliant health and patient
data ingestion, storage and processing across
functions, geographies and regulatory agencies
Accenture Life Sciences
ASOLUTIONDESIGNED
FORYOURENTERPRISENEEDS
Seamless collaboration
Empowers seamless, coordinated collaboration
across the enterprise—from research to
commercial—to unify teams with common insights
and objectives
Open & extensible
Leverages industry-leading, cloud-based
infrastructure with open interfaces to enable
flexible adoption with existing systems and
custom-developed extensions
Intelligence applied
Enables artificial intelligence, smart automation,
machine learning and advanced analytics— at
scale—to discover and apply new insights
Agility & innovation
Provides ready access to our external partner
network of digital innovation, removing barriers
to entry for you and leading-edge technology,
data and service providers
Market-proven
Already market-proven and trusted as a platform
of choice by eight of the top ten global life
sciences companies.
Copyright © 2020 Accenture. All rights reserved. 13
QUESTIONS?
KEVIN JULIAN
Senior Managing Director, Life Sciences
Accenture
LinkedIn
BRAD MICHEL
Managing Director, Life Sciences
Accenture
LinkedIn
Learn more: accenture.com/R-DSolutions
Copyright © 2019 Accenture. All rights reserved. 14
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Research and Development Solutions | Accenture

  • 2. Copyright © 2020 Accenture. All rights reserved. 2 WE HELP OUR CLIENTS SOLVE FOR PATIENTS Leverage data insights from across the life sciences ecosystem to transform how therapies are developed and patient care is delivered Connect with our combined life sciences passion and expertise to help you solve for patients Harness the digitalization of R&D and creatively apply connected technology solutions Accenture Life Sciences
  • 3. Our expertise in driving better outcomes for Life Sciences companies LIFESCIENCES INDUSTRYLEADERSHIP Accenture Life Sciences 3Copyright © 2020 Accenture All rights reserved. Leader In Digital & Commercial • Leader in all four IDC MarketScape Worldwide Life Sciences Sales and Marketing reports (Strategy/Consulting, BPO, IT, Digital) • Leader in Everest Group 2019 PEAK Matrix™ Life Sciences Digital Services • Ranked by Ad Age as the Largest Digital Network Agency in the world Leader in IT Application Services • Ranked as Top IT Services Vendor in Life Science Industry for five years in a row by IDC Health Insights • Positioned as Leader and Star Performer in Everest Group 2017 Life Sciences IT Application Services Assessment • Leader position on Everest Group’s PEAK Matrix™ for European Life Sciences ITO Leader in Real World Evidence • Received 2018 Frost & Sullivan Market Leadership Award for Real- World Evidence Enterprise Solutions Leader in Research & Development • Positioned as Top Leader in Everest Group 2020 Life Sciences Operations Services PEAK Matrix™ Assessment • Positioned as Leader in Everest Group 2019 PEAK Matrix™ for Data & Analytics Service Providers • Positioned as Leader and Star Performer in Everest Group 2017 Life Sciences Clinical and R&D IT Services Assessment • Positioned as a Leader in IDC MarketScape on Life Science Drug Safety Services, ITO, BPO and Strategic Consulting (2016, 2018)
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  • 6. Accenture Life Sciences RESEARCH& SCIENTIFIC INFORMATICS Experience in major lab informatics solution categories, including ELN, CDMS, LIMS, SDMS Multiple Industry Experience Life sciences, consumer products, oil and gas, agrochemical, government 25 years of domain experience and thought leadership Global delivery capabilities BUSINESS TRANSFORMATION • Operating model assessment and design • Operating model implementation • Creation of new entities spanning multiple commercial organizations • Project and change management • Business process harmonization COMPLIANCE • Validation services • CFR 21 Part 11 compliance MANAGED SERVICES • Production application support • Lab environment management • Scientific data management • Knowledge management TECHNOLOGY • INTIENT Research platform – custom cloud migrations and projects • Lab automation • Enterprise lab informatics system implementation • Enterprise scientific data management • Enterprise application integration • Machine learning and Artificial Intelligence planning and implementation CONSULTING • Informatics/IT road-mapping & strategy • Scientific partnership identification with commercial and academic organizations • Landscape evaluation from early discovery through to quality labs Scientific Informatics Center of Excellence 75% of team with background in chemistry, biology, and other sciences 6Copyright © 2020 Accenture All rights reserved.
  • 7. Accenture Life Sciences CLINICAL SERVICES CONSULTING • Digital Clinical Development Strategy • Operating Model Design and Implementation • Process Optimization, Change Management and Clinical Sourcing Strategy • Clinical Data Standards Strategy and Governance • Clinical Analytics Strategy OPERATIONS • Data Management: Medidata Rave, Oracle Inform and Medrio • Clinical Monitoring/Medical Writing • Clinical Data Transparency and Disclosure • Programming and Statistics MANAGED SERVICES • Business, Information and Technology Architecture Enabling End-to-End Data Flow • Investigator Payments • Database Setup, Closeout and Analysis including EDC Rave Implementation, Process, Integrations and Training • Clinical Application Management Services • Clinical Data Asset Review TECHNOLOGY • INTIENT Clinical platform • EDC and IRT Integration with CTMS, eTMF and other internal systems • Mhealth Technologies 7Copyright © 2020 Accenture All rights reserved. 1,350 clinical data services experts globally 8,500+ ADaM datasets created 2,500+ EDC Study Builds (35% InForm, 15% Rave) 1,500+ Databases Locked 4,635 clinical studies managed 1,200 studies mapped to SDTM 80+ SDTM-based submissions to the FDA 100+ CDISC submissions to the FDA 75,000+ TLFs Produced 6.5 million clinical research case report forms processed 14 TAs supported (Top 5 TAs: Immuno- Oncology, Cardiovascular, Respiratory, Vaccines, Neuroscience)
  • 8. Accenture Life Sciences REGULATORY SERVICES 8Copyright © 2020 Accenture All rights reserved. 4,000+ xEVMPD messages (Sept. 2013 to-date) 200 skilled Regulatory professionals 26+ therapeutic areas Submissions experience in 106 markets in over 90 countries 10,000+Health Authority submissions in 2018 950+ Regulatory applications maintained 20+ YEARS of Regulatory Operations Experience CONSULTING • Business / Process transformation • Program management • Regulatory compliance assessment and remediation programs (CMC, Labelling) • Change management • Training strategy & execution TECHNOLOGY • Technology strategy road mapping • IT transformation / Veeva RIM implementation • Regulatory automation engineering • Labelling automation solution • Authoring templates (StartingPoint) OPERATIONS • Regulatory strategy & advisory projects • CMC & Labelling management (incl. authoring, change coordination) • Major & LCM submissions management and production – Planning & compilation – Formatting & publishing – Dispatch, archiving & tracking
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  • 10. Accenture Life Sciences PATIENT SERVICES Global Delivery and Innovation centers in Barcelona, Dublin, India & the USA Business services, enabled by real-world analytics and proprietary technology, to drive measurable impact on patient outcomes 450Experienced patient services practitioners globally Offering expertise and serving patients across 14 therapeutic areas Engaged with 85% Of the world’s top 25 life sciences companies Serving 15+million patients In 19 countries REAL-WORLD OUTCOMES RESEARCH PERSONALIZED COMMERICAL EXECUTION PATIENT ENGAGEMENT SUPPORT INTEGRATED PATIENT CARE • OUTCOME: Create greater understanding of clinical and economic value • HOW: Drive deeper patient insight for design of studies, services, digital solutions, and commercial agreements • OUTCOME: Personalize experiences & improve commercial effectiveness • HOW: Bring novel data and insights to inform campaign design, content, and channels • OUTCOME: Improve initiation and compliance to prescribed treatment • HOW: Activate the healthcare community to increase awareness, access, and adherence • OUTCOME: Engage in patient care to support better treatment outcomes • HOW: Enable coordinated patient services, which provide improved support for clinical care 10Copyright © 2020 Accenture All rights reserved. • OUTCOME: Enable data and process integration to ensure coordinated delivery of care against critical timelines • HOW: Helps capture, store, import, standardize and analyze volumes of data for personalized patient treatment delivery PRECISION MEDICINE DELIVERY
  • 11. 11 PLATFORMTECHNOLOGY This new market reality is demanding … ▪ New Data ▪ New Value Measures ▪ New Therapeutic Solutions ▪ New Business Strategies ▪ New Collaborations ▪ New Technologies INTIENT MOVINGFROMAMBITIONTOACTION TM Accenture Life Sciences Copyright © 2020 Accenture. All rights reserved.
  • 12. INTIENT Applied Intelligence Data Management Secure Infrastructure Integrated Applications INTIENTNetwork Enabling access to a partner ecosystem of digital innovation. ™ INTIENT Patient INTIENT PV INTIENT Clinical INTIENT Research POWERED BYGOOGLECLOUD Copyright © 2020 Accenture. All rights reserved. 12
  • 13. Safe & secure Offers trusted and compliant health and patient data ingestion, storage and processing across functions, geographies and regulatory agencies Accenture Life Sciences ASOLUTIONDESIGNED FORYOURENTERPRISENEEDS Seamless collaboration Empowers seamless, coordinated collaboration across the enterprise—from research to commercial—to unify teams with common insights and objectives Open & extensible Leverages industry-leading, cloud-based infrastructure with open interfaces to enable flexible adoption with existing systems and custom-developed extensions Intelligence applied Enables artificial intelligence, smart automation, machine learning and advanced analytics— at scale—to discover and apply new insights Agility & innovation Provides ready access to our external partner network of digital innovation, removing barriers to entry for you and leading-edge technology, data and service providers Market-proven Already market-proven and trusted as a platform of choice by eight of the top ten global life sciences companies. Copyright © 2020 Accenture. All rights reserved. 13
  • 14. QUESTIONS? KEVIN JULIAN Senior Managing Director, Life Sciences Accenture LinkedIn BRAD MICHEL Managing Director, Life Sciences Accenture LinkedIn Learn more: accenture.com/R-DSolutions Copyright © 2019 Accenture. All rights reserved. 14