Document Services Meeting 2/11/04 - nescon.org

Document Services Meeting 2/11/04 - nescon.org

Global Strategic Sourcing Selection of CRO Service Providers Mary Kachinsky Associate Director, Procurement Pfizer, Inc September 20, 2004 Todays Objectives Provide a CRO Market Profile: Trends in the Industry Introduce a Strategic Global Sourcing Methodology 2 Agenda CRO Market Profile/Outsourcing Trends Seven Step Global Strategic Sourcing Process Service Provider Performance Management 3 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 (20002007) CAGR 13.1% 14.37 15 12.71 11.26 9.97 10 8.79 7.78 5.96 6.73 Key Key Growth Growth Drivers Drivers Need Need for for cost cost containment containment and and speed to market speed to market Increased Increased globalization globalization of of Pharma/ Pharma/

Biotech companies Biotech companies Increased Increased technological technological demands demands Use Use of of suppliers suppliers for for additional additional pieces of R&D supply pieces of R&D supply chain chain (e.g., (e.g., labs, labs, preclinical) preclinical) 5 Key Key Growth Growth Constraints Constraints 0 More More stringent stringent regulatory regulatory standards standards Project Project cancellations/delays cancellations/delays CRO CRO size/service size/service tradeoff tradeoff and and expansion potential expansion potential 2000 2001 2002 2003 2004 2005 2006 2007 Sources: Frost & Sullivan, 2003; Reuters; Data Monitor. 5 Key Driver: Pharma/Biotech Need for Cost Containment and Increased Speed to Market Will Drive Growth Cost Cost Pressures Pressures for for Pharma/Biotech Pharma/Biotech CROs CROs Can Can Deliver Deliver Quicker

Quicker and More Efficient and More Efficient Trials Trials Patent Patentexpirations/generic expirations/genericcompetition competition impacting impacting more more of oflarge large pharma pharma company company portfolios portfolios Specialized Specialized in in clinical clinicalresearch research and andcan can generate economies of scale generate economies of scale Utilize Utilizelatest latestdata data management managementtools tools && technologies as well as other technologies technologies as well as other technologies (e.g., (e.g.,patient patientrecruitment) recruitment) Can Can conduct conducttrials trials in inlower lowercost costregions regions Increase Increase prescription prescriptioncompetition competition Price Price regulation regulation in in Europe Europe &&Asia, Asia, with with

threats of reimportation in US threats of reimportation in US Reduce Reduce time time to to complete completetrials* trials* CROs CROscomplete completetrials trials30% 30%faster fasterthan thanpharma pharma companies* companies* CROs CROscomplete completetrials trialsininless lesstime timeacross acrossphases phases Increased Increased regulatory regulatory pressure pressureleads leads to to increasing R&D costs increasing R&D costs Clinical Clinicaltesting testingexpenses expensesrising risingby by11% 11%annually annually Need Needfor forlonger/more longer/morecomprehensive comprehensivetesting testing(e.g. (e.g. chronic/complicated chronic/complicatedconditions) conditions) Request Requestfor formore moredetailed detailedsafety/efficacy safety/efficacydata datafor for specific specificpopulation

populationgroups groups(e.g. (e.g.children, children,seniors) seniors) Number of Weeks 89 66 Lower LowerR&D R&Dproductivity productivity (spend (spend per per compound increasing; sales compound increasing; salesincreasing increasing at at slower slowerrates) 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 6 CRO Market Growth Driver: Global Pharma R&D Outsourcing Expected to Almost Double by 2010 Global Pharmaceutical R&D Outsourcing Market (20012010) 30% 28.3% 26.4% 25% 20% 16.6% 17.4% 18.3% 19.2% 21.7% 20.3% 23.1%

24.7% 15% 10% 5% 0% 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Source: Reuters Business Insight. 7 Growth Projections: U.S. Will Make Up An Increasingly Large Share of CRO Revenue World CRO Revenues by Region U.S. U.S. CRO CRO Share Share Growing Growing (20002007) 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% R&D R&Dspend spendremains remainslargest largest in inUS US given largest pharmaceutical given largest pharmaceutical market market R&D R&Dspend spendin in Europe/Asia Europe/Asia more more limited given limited given 50% 25% 51.5% 52.0% 53.7% 54.7% 55.9% 57.2% 58.5% Price PriceControls ControlsAnd AndOther OtherRegulatory Regulatory Factors

Factors Lower LowerRates RatesOf OfOutsourcing Outsourcing(Especially (Especially In Asia) In Asia) Still StillEmerging EmergingAsia AsiaMarket Market 59.8% Activity Activitywill willincrease increase in in Europe/Asia Europe/Asia but revenues will not grow but revenues will not grow proportionally proportionallygiven given lower lowerpricing pricing 0% 2000 Source: 2001 U.S. U.S. will will continue continue to to comprise comprise largest largest percentage percentage of of market market with with U.S. share growing from 51% U.S. share growing from 51% in in 2000 2000 to to nearly nearly 60% 60% in in 2007 2007

Europe Europe and and Asia Asia shares shares both both fall fall between 2000 and 2007 between 2000 and 2007 Reasons Reasons include: include: 2002 Frost & Sullivan, 2003. 2003 2004 2005 2006 2007 8 Biotech Firms Rapidly Growing in Importance in the CRO Market Space CRO R&D Expenditure Forecast (20002007) % of 100% Expenditure 23% 26% 30% 32% 34% 36% 38% 40% 73% 70% 68% 66% 64% 62% 60% 75%

Biotech 50% 77% 25% 0% 2000 2001 2002 2003 2004 2005 2006 2007 Source: Frost & Sullivan, 2003. 9 Pharma CRO Revenues Expected to Trend Lower in Phase III as Phase IV Revenues To Continue Higher CRO Revenues by Clinical Phase Pharmaceutical Companies (20002007) % of Revenue 100% 14.7% 15.5% 17.2% 18.8% 20.5% 22.2% 24.1% 26.1% 41.3% 39.3% 38.7% 37.2% 35.7% 34.2% 32.6% 31.1% Phase IV 75% 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 Shiftin inPhases PhasesMostly MostlyDue Dueto toPharmaceuticals PharmaceuticalsPursuing PursuingNew NewApplications Applications of Already Developed Drugs of Already Developed Drugs

Source: Frost & Sullivan, 2003. 10 Lower Cost Is Driving European Clinical Work From Western to Eastern Europe Western Western Europe Europe Strengths Eastern Eastern Europe Europe Critical markets for new drugs Clinical Activity Experience/credibility for development work Cultural similarities with U.S. allow cross-regional trials Weaknesses 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 Lowercosts costsas aswell wellas asavailability availabilityof ofservices servicesand andpatients patientsis isdriving drivingclinical clinical activity into Eastern Europe activity into Eastern Europe Top

Topplayers playerssuch suchas asCovance, Covance,Quintiles, Quintiles,PPDI, PPDI,and andIngenix Ingenixhave havelocations locationsin in Eastern Europe; others have begun to follow suit Eastern Europe; others have begun to follow suit Source: Frost & Sullivan, 2003. 11 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 Pharmaceutical Companies Small & Niche CROs <$50 MM 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. 12 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: Ireland-based Biological Laboratories in June 2002 Asia Parexel entered into exclusive co-marketing agreement with: Mitsubishi Chemical Safety Institute in 2001 PPD acquired: 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. 13 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 Greater employment stability in pharmaceutical and biotechnology companies lures CRO employees High turnover rates Develop innovative programs to attract and retain experienced personnel Sources:

Frost & Sullivan, 2003. 14 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 1. Identify Need and Pre-Project Planning 2. Define Project and Form Cross-Functional Team 7. Measure, Monitor and Report Performance Implementati on and Management Stage 6. Perform Supplier Selection 3. Collect Internal & External Data 4. Perform Strategic Analysis & Identify Opportunities 5. Formulate Strategies & Develop Implementation Plans 16 Strategy Stage Supplier Sourcing Includes Far More than Cost Reduction

Types Types of of Procurement Procurement Activities 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 17 Project Management Process &

Technology Change Management Process Facilitation Pfizer Current State: CR01 CR01 Pfizer CR06 Pfizer CR04 CR01 CRO5 Pfizer CR04 CR06 18 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 Sponsors 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 19 Strategic Relationships Offer Mutual Benefits Sponsor Benefits Service Provider Benefits Increased productivity Increased productivity Increased speed of engagement Better visibility into customers 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 20 Strategic Global Sourcing 7 Step Process Project Initiation Stage 1. Identify Need and Pre-Project Planning 2. Define Project and Form Cross-Functional Team 7. Measure, Monitor and Report Performance Implementati on and Management Stage 6. Perform Supplier Selection 3. Collect

Internal & External Data 4. Perform Strategic Analysis & Identify Opportunities 5. Formulate Strategies & Develop Implementation Plans 21 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 Key KeyConsiderations Considerations Dos Dosand andDonts Donts Protocol Key parameters Do understand clients 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 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 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 Key KeyConsiderations 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? Dos Dosand andDonts Donts 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? 23 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 Key Key Considerations Considerations Dos Dos and and Donts Donts 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) Financials Experience Compliance

Quality Capacity Geographic Reach Capability 24 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 25 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 26 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 27 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 Key Key Considerations Considerations 7. Measure, Monitor and Report Performance 3.

Collect Internal & External Data 6. Perform Supplier Selection Dos Dos and and Donts Donts 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 28 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 Definition Expresses desired output in legally enforceable terms. Describes what is wanted, when, where, how and at what quality or performance level. 1. Identify Need

and Pre-Project Planning 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 Poorly Written Written SOW SOW Risks Risks Well Well Written Written SOW SOW Benefits 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 customers buy-in

29 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 Key Key Considerations Considerations Dos Dos and and Donts Donts 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 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 Terms and Conditions 1. Identify Need and Pre-Project Planning Definition Negotiate terms and conditions of contract consistent with Pfizer standards Key Key Considerations 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) Dos Dos and and Donts Donts 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 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 Pricing 1. Identify Need and Pre-Project Planning Definition Negotiate pricing which generates mutual value for Pfizer and the service provider Key Key Considerations 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 Dos Dos and and Donts Donts 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 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 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 Key KeyConsiderations 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 Dos Dosand andDonts Donts 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 33 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 GLOBAL CLINICAL CLINICAL MONITORING MONITORING RACI RACI TASK TASK OWNERSHIP OWNERSHIP MATRIX MATRIX *IMPORTANT* *IMPORTANT* It It is is required required that that all all parties parties named named within

within this this document document be be directly directly involved involved in in its its completion completion and and be be in in full full agreement agreement with with the the RACI RACI distribution. distribution. KEY KEY PPT PPT -- Pfizer Pfizer Project Project Team Team (core (core team team overseeing overseeing clinical clinical trial trial activity) activity) N/A N/A -- Not Not applicable applicable CRO CRO Contract Contract Research Research Organization Organization PCO PCO -- Pfizer Pfizer Country Country Office Office R R Responsible Responsible for for completion completion of of task task A A Accountable Accountable for for completion completion of of task, task, even even though though responsibility responsibility may may be be delegated delegated to to another another group group

C C Must Must be be Consulted Consulted prior prior to to completion completion of of task task II Must be Informed of task completion Must be Informed of task completion All All services services delegated delegated to to the the CRO CRO must must be be conducted conducted in in accordance accordance with with ICH ICH Good Good Clinical Clinical Practise Practise guidelines guidelines and and must must be be conducted conducted in in accordance accordance with with all all local local laws laws and and regulations regulations SECTION SECTION 11 1.1 1.1 e v i t ra

Provide Provide the the initial initial Clinical Clinical Investigators Investigators Brochure Brochure (CIB), (CIB), final final Protocol, Protocol, CRF, CRF, questionnaires questionnaires and and Diary Diary Cards Cards (where (where applicable). applicable). Revise Revise Protocol, Protocol, CRF, CRF, Diary Diary Card Card and and CIB CIB as as required. required. Deliver Deliver copies copies of of protocol, protocol, CRF, CRF, Diary Diary Card Card and and numbered numbered copies copies of of CIB CIB to to CRO. CRO. Provide Provide a a template template subject subject information information sheet sheet and and informed informed consent consent form, form, to to include include local local data data privacy privacy sections. sections. Development Development (hardware,

(hardware, software software design design and and validation) validation) of of input input screens screens where where electronic electronic CRF CRF and/or and/or Diary Diary Card Card are are to to be be used. used. Deployment Deployment of of sufficient sufficient pre-loaded hardware to CRO where electronic CRF pre-loaded hardware to CRO where electronic CRF and/or and/or Diary Diary Card Card are are to to be be used. used. With With Pfizer, Pfizer, produce produce aa Study Study Procedures Procedures Manual Manual (incorporating study specific (incorporating study specific guidelines guidelines e.g. e.g. CRF CRF completion completion guidelines), guidelines), Investigator Investigator and and Country Country Files Files (based (based on on the the CROs CROs SOPs) SOPs) but but using using Pfizers Pfizers Trial Trial

Master Master filing filing system system (ELARA). (ELARA). All All documents documents to to be be reviewed reviewed by by Pfizer Pfizer prior prior to to finalization. finalization. Update Update the the Study Study Procedures Procedures Manual, Manual, Investigator Investigator and and Country Country Files Files during during the the course course of of the the Study Study as as aa result result of of any any protocol protocol amendments amendments or or other other significant significant changes changes to to the the Study Study and and // or or its its management. management. Prepare Prepare any any necessary necessary study study aids aids that that may may assist assist the the site personnel in running the Study, site personnel in running the Study, with with input

input and and approval approval from from Pfizer. Pfizer. Provide Provide local local language language translations translations of of all all informed informed consent consent documentation documentation to to Pfizer Pfizer country country offices. offices. 34 P CO O33 PC PCO O22 PC PCO O11 PC O CCRRO t s u l l I STUDY STUDY DESIGN DESIGN & & MATERIALS MATERIALS Design Design and and Development Development of of Clinical Clinical Study Study Documentation Documentation /A NN/A Clinical Clinical Monitoring Monitoring PT PPPT

SERVICE SERVICE TYPE: TYPE: 6. Final Selection 1. Identify Need and Pre-Project Planning Definition Select supplier(s) to move forward and begin implementation planning Key Key Considerations Considerations Dos Dos and and Donts Donts 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 35 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 Key KeyConsiderations Considerations Dos Dosand andDonts Donts 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 36 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 38 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 39 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 40 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) 41 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 42 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 43

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