accenture pfizer clinical trials evolution final2 - pega · pdf filedynamic case management,...

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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6

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


Geography & Channel


P E G A

S I T E H E A L T H


P v X


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


Geography & Channel


P E G A

S I T E H E A L T H


P v X



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


Geography & Channel


P E G A

S I T E H E A L T H


P v X



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


Geography & Channel


P E G A

G R A A B SS I T E H E A L T H


P v X



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


P R O P O S E D


Geography & Channel

G R A A B SS I T E H E A L T H


P v X


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

accenture pfizer clinical trials evolution final2 - pega · pdf filedynamic case management,...

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