Global Strategic Sourcing
Selection of CRO Service Providers
Mary Kachinsky
Associate Director, Procurement
Pfizer, Inc
September 20, 2004
Today’s Objectives
• Provide a CRO Market Profile: Trends in the Industry
• Introduce a Strategic Global Sourcing Methodology
1
Agenda
• CRO Market Profile/Outsourcing Trends
• Seven Step Global Strategic Sourcing Process
• Service Provider Performance Management
2
Agenda
 CRO Market Profile - Outsourcing Trends
The Strategic Global Sourcing Process
Service Provider Performance Management
R&D Outsourcing Trends Support CRO Market
Growth: Worldwide CRO Revenue to Grow to $14B+ by 2007
Worldwide CRO Revenue
Key Growth Drivers
(2000–2007)
CAGR
13.1%
14.37
15
12.71
•
11.26
•
•
9.97
10
•
8.79
7.78
Need for cost containment and
speed to market
Increased globalization of
Pharma/Biotech companies
Increased technological demands
Use of suppliers for additional
pieces of R&D supply chain
(e.g., labs, preclinical)
6.73
5.96
Key Growth Constraints
5
•
•
•
0
2000 2001 2002 2003 2004 2005 2006 2007
Sources:
Frost & Sullivan, 2003; Reuters; Data Monitor.
4
More stringent regulatory standards
Project cancellations/delays
CRO size/service tradeoff and
expansion potential
Key Driver: Pharma/Biotech Need for Cost Containment and
Increased Speed to Market Will Drive Growth
Cost Pressures for
Pharma/Biotech
•
Patent expirations/generic competition
impacting more of large pharma company
portfolios
•
Increase prescription competition
•
Price regulation in Europe & Asia, with
threats of reimportation in US
•
CROs Can Deliver Quicker
and More Efficient Trials
•
Specialized in clinical research and can
generate economies of scale
•
Utilize latest data management tools &
technologies as well as other technologies
(e.g., patient recruitment)
•
Can conduct trials in lower cost regions
•
Reduce time to complete trials*
– CROs complete trials 30% faster than pharma
companies*
– CROs complete trials in less time across phases
Increased regulatory pressure leads to
increasing R&D costs
– Clinical testing expenses rising by 11% annually
Number of Weeks
– Need for longer/more comprehensive testing (e.g.
chronic/complicated conditions)
– Request for more detailed safety/efficacy data for
specific population groups (e.g. children, seniors)
•
89 66
Lower R&D productivity (spend per
compound increasing; sales increasing at
slower rates)
* Benchmarking study by KMR Consulting of 2,800 Phase III trials in 2000.
Sources: Frost & Sullivan, 2003; Reuters; Data Monitor.
139
81
140
97
Phase I Phase II Phase III
Sponsor
CRO
5
CRO Market Growth Driver: Global Pharma R&D
Outsourcing Expected to Almost Double by 2010
Global Pharmaceutical R&D Outsourcing Market
(2001–2010)
30%
28.3%
26.4%
24.7%
25%
21.7%
20%
16.6%
17.4%
18.3%
19.2%
23.1%
20.3%
15%
10%
5%
0%
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Source:
Reuters Business Insight.
6
Growth Projections: U.S. Will Make Up An Increasingly Large
Share of CRO Revenue
World CRO Revenues by Region
U.S. CRO Share Growing
(2000–2007)
100%
$5.96
$6.73
$7.78
$8.79
3.0%
2.8%
2.6%
2.4%
10.7%
10.8%
10.3%
10.0%
$9.97 $11.26 $12.71 $14.37
2.2%
9.7%
2.0%
1.9%
1.7%
9.4%
9.1%
8.8%
Others
Asia
Europe
75%
34.8%
34.5%
33.4%
32.8%
32.1%
31.3%
30.5%
US
29.7%
51.5%
52.0%
53.7%
54.7%
55.9%
57.2%
58.5%
– Price Controls And Other Regulatory
Factors
– Lower Rates Of Outsourcing (Especially
In Asia)
– Still Emerging Asia Market
59.8%
– Activity will increase in Europe/Asia
but revenues will not grow
proportionally given lower pricing
0%
2000
Source:
• Europe and Asia shares both fall
between 2000 and 2007
Reasons include:
– R&D spend remains largest in US
given largest pharmaceutical
market
– R&D spend in Europe/Asia more
limited given
50%
25%
• U.S. will continue to comprise
largest percentage of market with
U.S. share growing from 51% in
2000 to nearly 60% in 2007
2001
2002
Frost & Sullivan, 2003.
2003
2004
2005
2006
2007
7
Biotech Firms Rapidly Growing in Importance in the
CRO Market Space
CRO R&D Expenditure Forecast
(2000–2007)
% of 100%
Expenditure
23%
26%
30%
32%
34%
36%
38%
40%
70%
68%
66%
64%
62%
60%
Biotech
75%
50%
77%
73%
25%
Pharma
0%
2000 2001 2002 2003 2004 2005 2006 2007
Source:
Frost & Sullivan, 2003.
8
CRO Revenues Expected to Trend Lower in Phase III
as Phase IV Revenues To Continue Higher
CRO Revenues by Clinical Phase
Pharmaceutical Companies
(2000–2007)
% of
Revenue
100%
14.7%
15.5%
17.2%
18.8%
20.5%
22.2%
24.1%
26.1%
38.7%
37.2%
35.7%
34.2%
32.6%
31.1%
Phase IV
75%
41.3%
39.3%
Phase III
50%
25.3%
26.2%
24.7%
24.3%
23.9%
23.4%
22.8%
22.2%
18.7%
19.0%
19.4%
19.7%
20.0%
20.2%
20.4%
20.6%
2000
2001
2002
2003
2004
2005
2006
2007
Phase II
25%
Phase I
0%
Shift in Phases Mostly Due to Pharmaceuticals Pursuing New Applications
of Already Developed Drugs
Source:
Frost & Sullivan, 2003.
9
Lower Cost Is Driving European Clinical Work From
Western to Eastern Europe
Western Europe
Eastern Europe
 Critical markets for new
drugs
Strengths
Clinical
Activity
 Experience/credibility for
development work
 Cultural similarities with U.S.
allow cross-regional trials
Weaknesses
•
•
Source:
– Research costs
approaching U.S. levels
(patent and physician
compensation increasing)
– Charges are for all
expenses incurred
 Much lower cost; particularly patient
and physician compensation levels
 Charges are typically for only costs
incurred over and above standard
operating expenses
 Reputation for quick and effective
recruitment
 Fewer patients on medications which
could disqualify them from trials
– Untested
– Cultural dissimilarities with West
and among Eastern European
nations (i.e., Language,
Demographics, etc.)
Lower costs as well as availability of services and patients is driving clinical
activity into Eastern Europe
Top players such as Covance, Quintiles, PPDI, and Ingenix have locations in
Eastern Europe; others have begun to follow suit
Frost & Sullivan, 2003.
10
Supplier Segmentation: CRO Competition Split Into Three Tiers
Focused on the Same Three Key End-user Groups
Tiers of Competition
Key End-User Groups
TIER 3
Small & Niche CROs
<$50 MM
Pharmaceutical
Companies
TIER 2
Biotechnology
Companies
Medium-Sized CROs
Some Global Capacity
$50–$150 MM
TIER 1
Government
Institutions
Large Global CROs
>$150 MM
Source:
Frost & Sullivan, 2003.
11
Notable Acquisitions and Mergers by Region
U.S.
Inveresk acquired:
•
ClinTrial Research to enter U.S.
Market in 2001
Charles River Laboratories
acquired:
•
•
•
•
•
Argus Laboratories
Sierra Biomedical
Worcester
Spring Boring Labs
Pathology Associates
Europe
Icon acquired:
•
U.K.-based Medeval Group Ltd., a
clinical pharmacology company that
provides Phase I services
Charles River Laboratories
acquired:
•
Asia
Parexel entered into exclusive comarketing agreement with:
•
Mitsubishi Chemical Safety
Institute in 2001
PPD acquired:
•
Ireland-based Biological
Laboratories in June 2002
ProPharma Pte Ltd., an Asian
CRO with broad experience in
dealing with pan-Asian clinical
trials in June 2002
to build its pre-clinical capability in
2001 and 2002
Life Sciences Research acquired:
•
Huntington Life Sciences Group plc
to enter U.S. market in 2001
Source:
Quintiles and U.K.-based BioFocus
launched:
•
New screening service for the rapid
and early detection of potential
cardiac side effects caused by drug
candidates and lead molecules in
February 2002
Frost & Sullivan, 2003.
12
Quintiles Japan K.K. and SRL,
Inc. formed a strategic alliance:
•
To provide clinical trial laboratory
services in August 2002
Quintiles acquired a controlling
interest in :
•
Health Research Solutions Pty
Ltd., an Australian CRO
specializing in multinational latephase clinical research
Strategic Responses to Key Market Challenges
Market Challenges
Lack of appropriately
trained and experienced
staff
Potential Outcomes
Loss of contract work for
CRO
Strategic Responses

• Evaluate full-time versus temporary
and contract staffing
– Enhance workforce expertise
– Reduce volatility in staffing levels
• Implement client communication
procedures to evaluate its services
Difficult to maintaining
close relationships with
sponsors
Rising client pressures
and expectations

Consolidation within CRO
industry
Shortage of partners and
acquisition targets to fuel
future growth
• Exploit M&A opportunities in the
short-term

• Plan for long-term organic growth
High turnover rates
• Develop innovative programs to

attract and retain experienced
personnel
Greater employment
stability in pharmaceutical
and biotechnology
companies lures CRO
employees
Sources:
Frost & Sullivan, 2003.
13
– Continuously evaluate their services
against client expectations
– Allows for improvements
– Maintains continuous communication
Agenda
CRO Market Profile – Industry Trends
 The Strategic Global Sourcing Process
Service Provider Performance Management
Strategic Global Sourcing – 7 Step Process
Project Initiation Stage
2.
Define Project
and Form
Cross-Functional Team
1.
Identify Need
and Pre-Project
Planning
7.
Measure,
Monitor
and
Report
Performance
Implementation
and
Management
Stage
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
15
4.
Perform Strategic
Analysis & Identify
Opportunities
Strategy
Stage
Supplier Sourcing Includes Far More
than Cost Reduction
Types of Procurement Activities
Strategic
Operational
• Category Management
• Quality
• Outsourcing
• Supplier Performance Management
• Total Cost of Ownership
• Order Fulfillment
• Process Mapping/ Improvement
• Client Relationship Management
• Supplier Management
• Contract Negotiation and Administration
• Quality
• Preferred and Improved Payment Methods
• Sourcing
• Supply Chain Efficiency
Toolkit
Data
Collection
Benchmarking
Data
Analysis
Negotiation
Industry
Best
Practices
Competitive
Intelligence
Global
Resources
Knowledge
Sharing
Market
Intelligence
16
Project
Management
Process &
Technology
Change
Management
Process
Facilitation
Pfizer Current State:
CR01
CR01
Pfizer
CR06
Pfizer
CR04
CR01
CRO5
Pfizer
CR04
CR06
17
• Wide variety of CROs
being used by Sponsor
company
• Lack of standardized
approach across sites
• Multiple independent
relationships between
some CROs and
different parts of
Sponsor company
• Lack of leverage of
Sponsor’s scale in
negotiations with
top CROs
Pfizer Future State…
• Build strategic
relationships
with core providers
• Create seamless
boundaries with providers
through standardized
processes, systems and
tools
• Improve performance
management and
oversight of providers
making providers an
extension of the rest of
our business
• Expand use of cost
effective alternate
resources
CR0-3
CR0-X
CR0-2
Pfizer
CR0-1
18
Strategic Relationships Offer Mutual Benefits
Sponsor Benefits
Service Provider Benefits
• Increased productivity
• Increased productivity
• Increased speed of engagement
• Better visibility into customer’s
outsourcing needs
• Standardized outsourcing
processes across divisions,
sites and regions
• More efficient use of resources
• Reduced oversight from Pfizer
• Better visibility/reporting into
performance of outsourced
activities
• Reduced rework
• More stability in outsourced
workforce
19
Strategic Global Sourcing – 7 Step Process
Project Initiation Stage
2.
Define Project
and Form
Cross-Functional Team
1.
Identify Need
and Pre-Project
Planning
7.
Measure,
Monitor
and
Report
Performance
Implementation
and
Management
Stage
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
20
4.
Perform Strategic
Analysis & Identify
Opportunities
Strategy
Stage
1. Identify Need
1.
Identify Need
and Pre-Project
Planning
Definition
Identify required needs of initiative, and obtain sponsor
and key stakeholder support
Do’s and Don’ts
Key Considerations
• Protocol – Key parameters
• Do understand client’s needs
• Understand skill, timeline,
training, and IT requirements
• Do determine costs of the
function being outsourced
• Definition of deliverable
• Budget approval
• Do align customer expectations
with sourcing strategy
• Understand context of initiative
and relationship to other
outsourcing activity
• Do engage sponsors and
stakeholders early in the
process
• Understand risk/issues and
urgency/visibility of initiative
21
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
2. Form Cross-Functional Team
1.
Identify Need
and Pre-Project
Planning
Definition
Determine initiative scope, timeline, key milestones, team
members, and roles and responsibilities
Do’s and Don’ts
Key Considerations
• Does team have access to key decisionmakers?
• Is collaboration of people from several
parts of the organization required?
• Does the initiative demand the
assignment of critical internal resources
(eg subject matter experts?)
• Is team aligned on expected deliverables,
and with customer expectations?
• Do form a cross-functional team
– Team members should represent
the product/service being
outsourced and/or those affected
by the product/service being
outsourced
• Do develop a workplan
• Do determine communication plan
• Is initiative scoped properly and have
appropriate timelines?
• How will team measure and report
progress?
22
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
3. Collect Internal and External Data
1.
Identify Need
and Pre-Project
Planning
Definition
Collect internal and external data to determine business
requirements, best practices, and supplier capabilities
Do’s and Don’ts
Key Considerations
• Supplier and industry
•
overview
• Industry cost structure
•
– Ex. PICAS
• Current spend analysis and
rate structure
• Supplier overview (RFI may
be needed to collect this
information)
– Experience
– Financials
– Quality
– Compliance
– Geographic Reach
– Capacity
– Capability
23
Do collect as much data as
possible
Do understand drivers of
service provided
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
Internal Quality Check List
Internal Quality Check List Includes:
• Financial Health Check
• D&B
• Quality Audit Performed
24
6. Select Supplier
1.
Identify Need
and Pre-Project
Planning
Supplier selection has 6 major workstreams:
• Issue a Confidentiality Agreement (CDA)
• Establish Master Service Agreement
• Create statement of Work
• Issue RFI/RFP
• Evaluate responses
• Negotiate
• Final Selection of Supplier
25
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
Evaluation Criteria
Criteria
CRO Evaluation Criteria
I. Financial Stability
Score/Weight
D&B Rating
Revenue Trend (last three years)
Revenue Per Employee
II. Service Capability
Score/Weight
Capacity
Geographic Reach
Therapeutic Expertise
III. Human Resources
Score/Weight
Voluntary Turnover Rate in % (last 3 years)
Qualified People
Years of Experience/Therapeutic Experience
IV. Quality Assurance
Score/Weight
Regulatory Audit
Date of Last Audit
483 Observations Cited?
Certifications (eg ISO 9000, other?)
Rating
Weight
Y/N
Y/N
Criteria
CRO Evaluation Criteria
V. IT
Score/Weight
CFR 21 Part 11 Compliance
Connectivity to internal systems
VI. Risk Benefit
Score/Weight
% of Business with Sponsor Company
M&A Status
Litigation
VII. Customer Service Level
Score/Weight
Ease of Service
Sponsor Studies (Year to Year Revenue)
Total Score
Score 1-5 Weight=26
Score 1-5 Weight=21
Score
1 = Fails to meet rqmts
2 = Partially meets rqmts
3 = Meets rqmts
4 = Exceeds rqmts
5 = Greatly exceeds rqmts
Score 1-5 Weight=16
26
Rating
Weight
Score 1-5
Weight=16
Y/N
Y/N
Score 1-5
Weight=26
Max of 25
100
6. Select Supplier – MSA
1.
Identify Need
and Pre-Project
Planning
Definition
Ensure single Master Service Agreement (MSA) is in
place to simplify and expedite agreement process
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
Do’s and Don’ts
Key Considerations
• Does an MSA already exist?
– Can it be amended to fit
specific needs?
• Do check if an MSA already exists
• Consistent terms and conditions,
and position on material issues
• Do use single global MSA where
possible
• Legal support model
• Requires cooperation with internal
customer groups
(monitoring/investigator issues)
– Ex. Investigator site selection,
co-monitoring
• Pre-established work order
templates and attachments
• Accommodates flexible pricing
models
• Do have an MSA in place
• Address systems and equipment
issues
27
2.
Define Project
and Form
Cross-Functional Team
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
6. Select Supplier – Statement of Work/Work Order
1.
Identify Need
and Pre-Project
Planning
Definition
Expresses desired output in legally enforceable terms.
Describes what is wanted, when, where, how and at what
quality or performance level.
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
Poorly Written SOW Risks
Well Written SOW Benefits
• Delivery of poor quality product or
services
• Solicits high quality, competitive, and
consistent proposals from each supplier
• Wasted time and money
• Unfavorable pricing
• Effective internal planning and
communication among work groups
involved in particular sourcing effort
• Contractual disputes and lawsuits
• Adequately defines the relationship
• Uninvited scrutiny by protesters,
attorneys, and/or government
officials
• Clearly describes roles and
responsibilities
• Clearly indicates metrics to determine
whether client requirements are met
• Links to protocol parameters
• Ensures customer’s buy-in
28
4.
Perform Strategic
Analysis & Identify
Opportunities
6. Select Supplier – Issue RFI/RFP and Evaluate
1.
Identify Need
and Pre-Project
Planning
Definition
Issue a Request for Information/Proposal (RFI/RFP) to
determine supplier background, capabilities, and pricing
Do’s and Don’ts
Key Considerations
• Ensure competitive bidding
environment
• Do prepare Request for
Information/Proposal
• Standardized data collection
from all suppliers
• Do confirm budget availability
• Adhere to ethical standards
• Adhere to sourcing strategy
• Consider alternative pricing
mechanisms
– Hourly rates and hours
– Unit based pricing
• Do ensure signed
confidentiality agreement
• Do compare RFI/RFP
responses
• Do clarify details (as required)
• Do ensure completeness and
consistency across bids
29
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
6. Select Supplier – Negotiate Terms and Conditions
1.
Identify Need
and Pre-Project
Planning
Definition
Negotiate terms and conditions of contract consistent
with Pfizer standards
Do’s and Don’ts
Key Considerations
• Templates either already exist or
are in progress for range of CRO
services
– MSA
– Clinical Standards
– Work Order
– Change Order
– Equipment Schedule
• Type of Relationship
– Full Service (ex. Many services)
– Functional Service Provider (ex.
Biometrics)
– Staff Augmentation (contractors
to fill internal resource gap)
• Do link to MSA and Milestones
• Do leverage existing
templates/materials
• Do understand type of
relationship
• Do contact appropriate Vendor
Relationship Lead to determine
whether an agreement is
already in place
30
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
6. Select Supplier – Negotiate Pricing
1.
Identify Need
and Pre-Project
Planning
Definition
Negotiate pricing which generates mutual value for Pfizer
and the service provider
Do’s and Don’ts
Key Considerations
• The more information you
have the more prepared you
are for negotiation
• Understand vendor cost
structure
• Understand key study cost
drivers
• Investigate alternative work
structures and pricing models
• Productivity improvements vs.
escalators
• Trade items of unequal value
• Do leverage existing data and
tools
• Do exercise caution around
providing information which
reduces competitive
– Unit of Measure
– Units
advantage/leveragability
– Resources
– Timeline
various
pricing
– cost
• Do consider
variables
– Site
– Therapeutic area
– Phase
– Study location
31
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
6. Select Supplier – Negotiate Other Key Elements
1.
Identify Need
and Pre-Project
Planning
Definition
Negotiate other key elements (Task Ownership,
Deliverables, IT Requirements, Etc.) required
Do’s and Don’ts
Key Considerations
• Timeline requirements
• Payment implications
• Definition of deliverable
achievement
• Service level around deliverables
– Ex. All CRFs will be entered (first
and second pass) within x
business days of allocation by
Pfizer
• Clearly defined IT requirements
(incl. asset allocation and disposal)
• Communication requirements
– Meeting frequency and
participants
• Standards, SOPs, and training
requirements
• Do develop Task Ownership Matrix
• Do agree upon deliverables and
requirements
• Do develop IT connectivity plan and
application access plan
• Do finalize metrics collection and
calculation
• Do finalize key study data capture
process
32
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
Sample Tools
Task Ownership Matrix Example
GLOBAL CLINICAL MONITORING RACI TASK OWNERSHIP MATRIX
*IMPORTANT* It is required that all parties named within this document be directly involved in its’
completion and be in full agreement with the RACI distribution.
KEY
PPT - Pfizer Project Team (core team overseeing clinical trial activity)
N/A - Not applicable
CRO – Contract Research Organization
PCO - Pfizer Country Office
R – Responsible for completion of task
A – Accountable for completion of task, even though responsibility <R> may be delegated to another group
C – Must be Consulted prior to completion of task
I – Must be Informed of task completion
All services delegated to the CRO must be conducted in accordance with ICH Good Clinical Practise guidelines
and must be conducted in accordance with all local laws and regulations
SECTION 1
1.1
STUDY DESIGN & MATERIALS
Design and Development of Clinical Study Documentation









Provide the initial Clinical Investigators Brochure (CIB),
final Protocol, CRF, questionnaires and Diary Cards
(where applicable).
Revise Protocol, CRF, Diary Card and CIB as required.
Deliver copies of protocol, CRF, Diary Card and
numbered copies of CIB to CRO.
Provide a template subject information sheet and
informed consent form, to include local data privacy
sections.
Development (hardware, software design and
validation) of input screens where electronic CRF and/or
Diary Card are to be used. Deployment of sufficient
pre-loaded hardware to CRO where electronic CRF
and/or Diary Card are to be used.
With Pfizer, produce a Study Procedures Manual
(incorporating study specific guidelines e.g. CRF
completion guidelines), Investigator and Country Files
(based on the CROs SOPs) but using Pfizer’s Trial
Master filing system (ELARA). All documents to be
reviewed by Pfizer prior to finalization.
Update the Study Procedures Manual, Investigator and
Country Files during the course of the Study as a result
of any protocol amendments or other significant
changes to the Study and / or its management.
Prepare any necessary study aids that may assist the
site personnel in running the Study, with input and
approval from Pfizer.
Provide local language translations of all informed
consent documentation to Pfizer country offices.
33
PCO3
PCO2
PCO1
CRO
N/A
Clinical Monitoring
PPT
SERVICE TYPE:
6. Final Selection
1.
Identify Need
and Pre-Project
Planning
Definition
Select supplier(s) to move forward and begin
implementation planning
Do’s and Don’ts
Key Considerations
• Strategic/preferred suppliers
• Do obtain stakeholder buy-in
• Pricing
• Do communicate decision
• Capabilities
• Do finalize contract(s)
• Documentation/justification of
decision made
• Do determine implementation
timeline
34
2.
Define Project
and Form
Cross-Functional Team
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
7. Measure, Monitor, and Report Performance
1.
Identify Need
and Pre-Project
Planning
Definition
Measure, monitor, and report supplier performance
• Agree to metrics plan
• Link business requirements to supplier
performance targets
• Manage and monitor supplier
performance:
– Process
– Quality
– Cost
– Speed
– Compliance
– Etc.
7.
Measure,
Monitor
and
Report
Performance
3.
Collect
Internal &
External
Data
6.
Perform
Supplier
Selection
Do’s and Don’ts
Key Considerations
• Do establish service provider
program
• Do measure performance
• Do manage supplier an ongoing
basis
• Do determine savings
• Do communicate supplier review
output
• Perform savings validation and reporting
• Perform periodic reviews
35
2.
Define Project
and Form
Cross-Functional Team
5.
Formulate
Strategies & Develop
Implementation Plans
4.
Perform Strategic
Analysis & Identify
Opportunities
Agenda
CRO Market Profile/Outsourcing Trends
The Strategic Global Sourcing Process
 Service Provider Performance Management
Key Steps to Service Provider
Performance Management
The Service Provider Performance Management process using the
following key steps
Step 1
Step 2
Step 3
Step 4
Define CRO
Supplier
and Services for
Performance
Evaluation
Develop Goals,
Review Frequency
and Scorecard
Gain Commitment
From Suppliers
Perform Supplier
Evaluation
Step 8
Step 7
Step 6
Step 5
Post Evaluation
Results in the
Internal Database
Develop
Continuous
Improvement Plan
Meet With
Suppliers for
Periodic
Performance
Review (PPR)
Communicate
Evaluation Results
to Internal
Stakeholders and
Suppliers
37
Key messages – Metrics
1. Develop appropriate metrics to support your organization
– Example: Cost, Quality and Speed metrics for tracking CRO performance
2. Metrics can be leveraged for specific outsourcing situations
– Recruiting and Monitoring
– Data Management
– Biostats and Reporting
– Full Service Outsourcing
38
Applicable metrics
SSP Metrics – Speed (sample)
CRO
Recruiting and
monitoring
Metrics
1. Lead time between receipt of the complete protocol pack
at the country and the date of full external approval *
2. Recruitment Reliability (subject recruitment progress
compared with agreed target patient numbers and
timelines) *
3. Recruitment Rate (number of subjects randomized per
month at each study center)*
4. Lead-time between a patient visit and the arrival of the
data in-house*
5. Average time from CRF page received to entry complete
6. Time between last CRF in house and database lock
7. Time between DB lock to top-line report
8. Time between top-line report to final monitoring study report
9. Time between Protocol approval to FSFV
10. Time between Protocol approval to 50% of sites have a
FSFV
11. Time between FSFV to LSFV
12. Time between LSLV to Database lock
39
Data
Management
Biostats and
reporting
Full-service
outsourcing
Applicable metrics
SSP Metrics – Quality (sample)
CRO
Recruiting and
monitoring
Metrics
1. Number of protocol violations/waivers
2. Screening failure rate
3. Patient retention rate
4. Number of Data Clarification Forms issued
per 100 Data Capture Modules*
5. Number of times database is unlocked/unfrozen
due to database errors
6. Number of iterations between locked
database to final tables
7. CQA audit rating**
8. CRO project management quality
(from DOTL/CSM survey)
40
DM
B&R
Full-service
Applicable metrics
SSP Metrics – Cost (sample)
CRO
Metrics
Recruiting and
monitoring
1. Monitoring cost per patient
2. Data management cost per page and/or
per data collection module (DCM)
3. B&R cost per table/listing/figure
4. Overall cost per patient
5. Project mgmt cost as a percent of
total study cost
6. Budgeted cost vs. actual cost
41
Full-service
DM
B&R
Performance Metrics Usage Guideline
• Purpose of CRO Performance Metrics
– Establish a performance management tool to measure and improve
vendor performance
– Facilitate future decision making around outsourced work and
strategic vendors
• Reporting Frequency: quarterly
• Format: metrics reported at appropriate level (e.g., vendor, study, country)
• Reporting responsibility
– Short-term: pilot with a few CROs (perhaps manual effort)
– Long-term: establish system based reporting enabling internal automatic metrics
reports through CROs feeds
42