accenture pfizer clinical trials evolution final2 - pega · pdf filedynamic case management,...
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About Pfizer
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Revenue (1) $49.60BEnterprise Value (1) $209.75BEmployees 78,300
Founded 1849Headquarters New York, New York
Pfizer Inc., a biopharmaceutical company, discovers, develops, manufactures, and sells healthcare products worldwide. Key disease areas of focus in Oncology, Biosimilars, Inflammation and Immunology, Neuroscience & Pain, Vaccines, Rare Diseases, and Cardiovascular & Metabolic Diseases
Source: Finance.yahoo.com as of Dec 31, 2014
Industry Challenges
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Time(10 – 15 Years)
Cost(> $2B)
Complexity(Drug Protocol)
PR
E -
DIS
CO
VE
RY
DRUG DISCOVERY
PRE-CLINICAL CLINICAL TRIALS FDA
REVIEWLG-SCALE
MFG
5,000 – 10,000COMPOUNDS
250
PHASE2
100 - 500
PHASE3
1,000 – 5,000
ONE FDA-
APPROVED
DRUG
3 – 6 YEARS 6 – 7 YEARS 0.5 – 2 YEARS
5
250PHASE1
20 - 100
SOURCE:INNOVATION.ORG
IND
SU
MIT
TED
ND
A S
UB
MIT
TED
NUMBER OF VOLUNTEERS
Clinical Trials Journey
Study Design
Study Startup
Study Conduct
Study Closeout
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Study Design
Study Startup
Study Conduct
Study Closeout
Driving Site Health
Path to Sustainable Quality As a sponsor, Pfizer is responsible for ensuring appropriate oversight of all its clinical trials
Clinical Trials Security and Compliance (CTSC) unit provides oversight and support to Investigators through the Alliance Partner Model to ensure clinical trial quality
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Study Design
Study Startup
Study Conduct
Study Closeout
Quality Management Framework
Quality Planning
Quality Control
Quality Improvement
Clinical Trials Oversight Challenges• Highly manual processes to share oversight findings with Alliance
Partner personnel running the clinical trial• Existing solution offering was antiquated (Microsoft
SharePoint/Word)• Limited options to move to the world of centralized and risk-based
oversight• Existing system design did not align to increased, centralized and
remote oversight business requirements• Existing platform did not integrate easily with other data sources• Existing solution could not deliver the expected web capabilities
and platform support desired now, and into the future• Analytics did not exist to identify areas where centralized oversight
can substitute for onsite visits
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Study Design
Study Startup
Study Conduct
Study Closeout
• Increase efficiency of clinical trial execution• Advance Pfizer ahead of industry peers through continuously
cumulative insights and experience• Deliver data-driven insights to support Pfizer interactions with
investigators and regulators and take targeted actions• Adopt TransCelerate RBM Concepts
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ObjectivesStudy
DesignStudy
StartupStudy
ConductStudy
Closeout
Business Solution
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Study Design
Study Startup
Study Conduct
Study Closeout
Supporting TechnologiesStudy
DesignStudy
StartupStudy
ConductStudy
Closeout
1. Analytics
R-Engine
3. Visualization
Spotfire
2. Process Orchestration
Pega
4. Data Aggregation
Data Mart
Key Considerations in Choosing Solution• A recognized Market leader in BPM,
Dynamic Case Management, CRM based on Pega’s process-centric approach
• Create intent-led user experience specialized based on any circumstance
• Fully unified solution for automating the development of business applications and the resolution of business processes
• Foundation Framework has been developed on industry best practices
• Highly configurable, rules-driven system • Specialized for business automation through
dynamic case management• No need for a separate Design Application
that would require rules and processes to be moved from design time to run time for testing and execution of the applications
• Unified Platform• Process Centric Approach• Legacy Modernization and Transformation• Empower the Business to Own the Change• Change the Organization Structure to Meet
Market Demands• Easily/Quickly innovate with New Products
and Services• Expand Solutions Globally• Drive Agility and Automation• Demonstrate ROI and COST Savings• Foster Great Customer Experiences• Supports widest possible array of integration
and connectivity standards
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Study Design
Study Startup
Study Conduct
Study Closeout
Key Considerations, contd.
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Study Design
Study Startup
Study Conduct
Study Closeout
Selected Components
• PegaRULESProcess Commander
• Lifesciences Industry Framework
• Business Intelligence Exchange
Requirements FeatureEnable management./conduct of oversight activities –Resource assignments, documentation of oversightactivities including on-site visits and/or remote riskdata review and managing issues and documenting Resolution
For FDA purpose ability to capture the change that wasmade, user who made the change and change time stamp
Ability to capture Audit trails on the records
Ability to export a Study Oversight Plan into a PDF format
Data Analytics and Predictive Modeling (Future)
Ability to integrate with various components of HealthMonitoring into a “one stop shop” for all oversightactivities
Ability to execute “canned” and “ad-hoc” reports
• Dynamic Case Management Auditable Notifications
• LS Field AuditingAuditable Notifications
• PRPC auditing capability
• LS Reports & PDF Form generation
• RBAM – Risk Based Activity Monitoring (Future)
• Connector Support
• Reports
Driving Site Health Journey
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Study Design
Study Startup
Study Conduct
Study Closeout
Functional Scope
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Study Design
Study Startup
Study Conduct
Study Closeout
Solution Framework
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S P O T F I R ES I T E H E A L T H
INF
OR
MA
TIC
A
DA
TA
MA
RT
INF
OR
MA
TIC
A
S E C U R I T Y
S Y S T E M 1
S Y S T E M 2
B I X
R - E N G I N E
DA
TA
MA
RT
…
S Y S T E M 3
R E A D W R I T E
E N T E R P R I S E R U L E S E T
SCOPE
…
…
…
…
O T H E R S
DOWNSTREAMUPSTREAM SCOPE
Study Design
Study Startup
Study Conduct
Study Closeout
Change Management & Service Introduction
WorkshopsReconfirm ScopeSprint PlanningUser StoriesHigh‐Level ArchitectureDesignValue FrameworkProject Kickoff
User Acceptance Testing
Refactoring through continuous business Feedback
Test Scripts Functional Testing Integration Testing
Deploy
Sprint 1 Sprint 2 Sprint 3 Sprint N
User Socializations
Project Roadmap & Estimate
Sprint 1
Sprintg 3
Sprint N
Sprint 2
Sprint Mgmt.
Implementation Methodology
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An AGILE approach that incorporated business feedback and SDLC procedures throughout the development life cycle.
Benefits• Modular methods to design and build• Design patterns to manage complex business
needs• Creation of reusable and decoupled
components• Fosters a Collaborative Working Approach • Handles the Complexity of Business
Processes through separation of concerns;
Outcomes• Improved efficiency
and productivity• Increased pattern
recognition• More effective library
maintenance• Component reuse• Higher quality
Site Health Foundation Block• Site Health Pega foundation code allowed Pfizer to generate reuse
platform for subsequent applications• The reuse saved schedule development time and dollars
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Reuse
Specialize byCustomer, Product,
Geography & Channel
Continuously ImproveQUALITY and Transform Clinical Trials Execution
P E G A
S I T E H E A L T H
S I T E H E A L T H F R A M E W O R K
P F I Z E R - E N T E R P R I S E - W I D E
Study Design
Study Startup
Study Conduct
Study Closeout
Solution Summary• Pfizer has a robust tool that will
enable their resource to more efficiently assess trends
• The Manual Review process is retired • There are no significant changes to
everyday practices for the study teams
• ~1300 requirement specifications in 5 months with no custom coding
• Leveraging out of the box a case management/BPM tool with out-of-the-box UI, business rule capabilities, reporting functions, work flows
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Take Home Message: Improved data quality thru faster issue identification, and more proactive management of site issues without additive resources
CountryRollout
80+ Users Rollout 300+
Assets 190+ Studies 950+
Oversight Plans (Study)
500+ Oversight Reports (Site)
18k+ Issues & Actions 59k+ & 82k+
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Study Design
Study Startup
Study Conduct
Study Closeout
Pharmacovigilance Exchange
Business Challenge• Business Challenge
– Manually managing individual agreements, with multiple partner organizations, with a significant number of individual products in scope
– Continuous assessment of the benefit risk analysis of the overall clinical trial process
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Study Design
Study Startup
Study Conduct
Study Closeout
• Solution:– Leverage existing Pega assets
and supports to capture Pharmacovigilance agreements
– Capture responsibilities of each partner for various activities in Agreements
– Periodically monitor these responsibilities.
Pharmacovigilance Exchange
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Study Design
Study Startup
Study Conduct
Study Closeout
Benefits:• Implemented a more holistic risk based auditing system of PVA partners through capturing the contractual
agreements between the Marketing Authorization Holders (MAH) and their Pharmacovigilance responsibilities• Centralized tracking and monitoring of Agreements as per customer’s SOPs and procedures and execution of
those commitments contained within PVAs on a global basis
Reuse
Specialize byCustomer, Product,
Geography & Channel
Continuously ImproveQUALITY and Transform Clinical Trials Execution
P E G A
S I T E H E A L T H
S I T E H E A L T H F R A M E W O R K
P v X
P F I Z E R - E N T E R P R I S E - W I D E
S I T E H E A L T H 2 . 0
~30% reuse
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Study Design
Study Startup
Study Conduct
Study Closeout
Randomization Schedules
Randomization Schedules• Business Challenge
– Various tools and procedures are in place to create and maintain Randomization Schedules
– Need to standardize and automate Randomization Schedule process.
– Controlling access to these randomization codes
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Study Design
Study Startup
Study Conduct
Study Closeout
• Solution:– Currently automating 7 manual
processes through GRAABS system using Pega Life Sciences Industry Foundation (LSIF) and Dynamic Case Management frameworks and Pega reusable assets as a base
GRAABS
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Reuse
Specialize byCustomer, Product,
Geography & Channel
Continuously ImproveQUALITY and Transform Clinical Trials Execution
P E G A
S I T E H E A L T H
S I T E H E A L T H F R A M E W O R K
P v X
P F I Z E R - E N T E R P R I S E - W I D E
S I T E H E A L T H 2 . 0
G R A A B S
P v X 2 . 0
Study Design
Study Startup
Study Conduct
Study Closeout
~50% reuse
• Benefits:– Authoritative and Administrative Source for Randomization Schedules– Enable distribution of treatments among the study’s patients without any bias– Provides users with an audit trail of the process– Efficiency in randomization scheduling process
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Study Design
Study Startup
Study Conduct
Study Closeout
Informed Consent Document (Pilot)
Business Challenge• An ever-increasing number of
locations, people and resources to acquire information to
– Improve on “getting things done”• The situation is an ongoing
challenge of balancing resources to meet the ultimate goal of providing solutions for the unmet needs of our patients
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Study Design
Study Startup
Study Conduct
Study Closeout
• Solution– Using Informed Consent
Documentation as a Pilot Process• Provide a centralized and a single
point of access for the tools, knowledge, and metrics and measures to the colleagues
• Transform the way Pfizer and vendors work, and access information and resources critical to clinical development while enhancing data quality and ensuring patient safety
Quality Connect – ICD Pilot
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Q C P i l o t ( I C D )
Study Design
Study Startup
Study Conduct
Study Closeout
In Progress
• Benefits*– One Place for Knowledge (Quality & Process) - Provide a single point of access and show a comprehensive
view of processes– Enhance Clinical Development – Simplify the documentation landscape and provide in-time and relevant
information tailored to users to perform their roles an responsibilities– Enhanced process controls– Reduced effort to locate necessary information– Reduced effort and cost in automated process
Reuse
Specialize byCustomer, Product,
Geography & Channel
Continuously ImproveQUALITY and Transform Clinical Trials Execution
P E G A
S I T E H E A L T H
S I T E H E A L T H F R A M E W O R K
P v X
P F I Z E R - E N T E R P R I S E - W I D E
S I T E H E A L T H 2 . 0
G R A A B S
P v X 2 . 0
~50% reuse
NEXT
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Pega Reuse & Specialize At Pfizer
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Reuse
Specialize byCustomer, Product,
Geography & Channel
Continuously ImproveQUALITY and Transform Clinical Trials Execution
P E G A
G R A A B SS I T E H E A L T H
S I T E H E A L T H F R A M E W O R K
P v X
P F I Z E R - E N T E R P R I S E - W I D E
Q C P i l o t ( I C D )
P R O P O S E D
Study Design
Study Startup
Study Conduct
Study Closeout
Conclusion
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P E G A
ReuseP F I Z E R - E N T E R P R I S E - W I D E
Continuously ImproveQUALITY and Transform Clinical Trials Execution
P R O P O S E D
Specialize byCustomer, Product,
Geography & Channel
G R A A B SS I T E H E A L T H
S I T E H E A L T H F R A M E W O R K
P v X
Q C P i l o t ( I C D )
F U T U R E
2 0 1 3 - 1 4
2 0 1 3 - 1 4
2 0 1 3 - 1 4 2 0 1 4 - 1 5 2 0 1 4 - 1 52 0 1 5
Study Design
Study Startup
Study Conduct
Study Closeout
Q & A