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5/15/2014 1
Beyond CTMS. Beyond Operational Metrics.
True Performance.Our webcast will begin in 15 minutes
To access audio via a conference line,please dial (949) 229-4400
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Beyond CTMS. Beyond Operational Metrics.
True Performance.Our webcast will begin in 10 minutes
To access audio via a conference line,please dial (949) 229-4400
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Beyond CTMS. Beyond Operational Metrics.
True Performance.Our webcast will begin in 5 minutes
To access audio via a conference line,please dial (949) 229-4400
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Beyond CTMS. Beyond Operational Metrics.
True Performance.Our webcast will begin in 1 minute
To access audio via a conference line,please dial (949) 229-4400
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Welcome and Introductions
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Housekeeping
Welcome
• To access audio via a conference line, please dial (949) 229-4400
• Join us in live tweeting about the event, using #croanalytics
• To submit a question:• Via Twitter #croanalytics.com• Via text at (215) 840-9252• Via email: [email protected]
• Presentation will be distributed via email following the presentation
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Peter Malamis
Chief Executive Officer,
Founder
Dr. Michael Howley
Chief Scientific Officer, Founder
Laurie Furiness
Executive Vice President, Operations
Matthew Schmidt
Matthew Schmidt Design
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Adding Value to Clinical Trials
Introducing PERFORMER™
Peter Malamis, CEO
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Thank You for Joining Us
Attending today are representatives from:• Sponsors• Full Service Research Providers• Small and Large Companies• Clinical Personnel• Outsourcing Personnel• Variety of Functional Areas and Functional Service
Providers
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• Cloud-Based Platform• Collects Quality Assessments From Anyone Associated With
Your Clinical Research• At Multiple Stages Of That Research, • Using Statistically Validated Tools • That Provide :
• Internal And External Quality Benchmarking, • Key Driver Identification And Analysis, And • Predictive Analytics.
PERFORMER™
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• Reports data in a way that helps you understand what’s working well, what’s not, and why
• Speeds the decision making that improves the efficiency and effectiveness of your clinical research
PERFORMER™
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Our First User Module for PERFORMER™ is the Trial Management And Oversight Module. This is for Clinical Trials in Phase 2, Phase 3, and Phase 4
PERFORMERTM SUITE
TRIAL ASSESSMENT MODULE
• Investigator Sites• Risk-Based Monitoring• Phase 1 Trial Management • Device Trial Management • Functional Areas
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ASSESSMENT ASSESSMENTASSESSMENT
Trial Management
Corporate Strategy
Functional Area Improvement
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ASSESSMENT ASSESSMENTASSESSMENT
Trial Management
Corporate Strategy
Functional Area Improvement
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• Multiple stage collection• Multiple personnel• Automated reminders• All data collection and reporting on-line
Trial Management & Oversight Corporate Strategy
Functional Area Improvement
Sales and Contracting
Trial Manager
Study Start-Up
Study Close-Out
Study Conduct
Functional Area Manager
FAM2 FAM3 FAM4 FAM5
Alliance Governance
Resource Allocation
Vendor Selection
Overall Performance
Benchmarking Key Driver Analysis Predictive Analytics
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Measuring Clinical Trial Performance: PERFORMER™
Michael Howley PA-C, PhDChief Scientific Officer
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Scientific Performance Measurement
State of Clinical Trial Performance Measurement
1. Metrics Misapplication
2. Incomplete Measurement
3. Benchmarking to Averages
4. Limited Efficiency
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1. Measure the right things
2. Validate your items
3. Link performance to quality
Predictive Modeling
Trial Performance
Activities
Clinical Trial
Quality
Customer Satisfaction
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5/15/2014 25This data is available in ‘High Performing Study Startups,’ forthcoming in Applied Clinical Trials, available online at http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/Online+Extras/High-Performing-Study-Start-Ups/ArticleStandard/Article/detail/820226?contextCategoryId=47497
Project Mgr Perf
(3)
.98
.95
.96
.97 IP Skill
6a
6b
6c
6d
.49
.25
.51
.42Know
(4)
5b
5c
.46
5a
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Clinical Trial
Quality
Sales & Contracting
Conduct Quality
Closeout Quality
Startup Quality
Timelines
Alignment
CRA Perf
Coll Ess Docs
Ability Identify Qual Inv
Recruiting Timelines
-.21
.27
.25
-.12
.24
.22
.35Project Mgr Perf
.46
.49
.97 IP Skill
6a
6b
6c
6d.98
.96
.95
.42
Know 5b
5c
.25
.51
5a
Scientific Performance Measurement
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Scientific Performance Measurement
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Designing PERFORMER™
Matthew SchmidtMatthew Schmidt Design
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Develop sophisticated and progressive design
• Collect Comprehensive Data• User-friendly Interface• Dynamic Reporting Tools
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Operations Perspective: Why PERFORMER™?
Laurie Furiness, EVP, Operations
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From a user’s perspective
Why PERFORMER™?
• Qualitative assessments translated to quantitative validated data
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From a user’s perspective
Why PERFORMER™?
• Qualitative assessments translated to quantitative validated data
• Accesses all parties performance: sponsor, CRO, all 3rd parties
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From a user’s perspective
Why PERFORMER™?
• Qualitative assessments translated to quantitative validated data
• Accesses all parties performance: sponsor, CRO, all 3rd parties
• Collect data at anytime, real-time allows for immediate action
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From a user’s perspective
Why PERFORMER™?
• Qualitative assessments translated to quantitative validated data
• Accesses all parties performance: sponsor, CRO, all 3rd parties
• Collect data at anytime, real-time allows for immediate action
• Includes professional skills assessment data
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From a user’s perspective
Why PERFORMER™?
• Qualitative assessments translated to quantitative validated data
• Accesses all parties performance: sponsor, CRO, all 3rd parties
• Collect data at anytime, real-time allows for immediate action
• Includes professional skills assessment data
• Adjunct to existing operational/financial metrics
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From a user’s perspective
Why PERFORMER™?
• Qualitative assessments translated to quantitative validated data
• Accesses all parties performance: sponsor, CRO, all 3rd parties
• Collect data at anytime, real-time allows for immediate action
• Includes professional skills assessment data
• Adjunct to existing operational/financial metrics
• Time commitment on project staff at all levels is nominal
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From a user’s perspective
Why PERFORMER™?
• Qualitative assessments translated to quantitative validated data
• Accesses all parties performance: sponsor, CRO, all 3rd parties
• Collect data at anytime, real-time allows for immediate action
• Includes professional skills assessment data
• Adjunct to existing operational/financial metrics
• Time commitment on project staff at all levels is nominal
• System is flexible, scalable, affordable
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What Is the Value in the Data?True Performance Quality Assessment allows for Root Cause Evaluation, Ultimately Leading to Predictive Analytics
Standard Reports
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What Is the Value in the Data?• True Performance Quality Assessment Allows For Root Cause Evaluation
Ultimately Leading to Predictive Analytics.
• Standard Reports
• Customized Reports
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PERFORMER™ Utility
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Questions Performer Can Answer• For My Company, I Want to See
• Project manager performance during study conduct by therapeutic area for all studies completed in the last 24 months compared to the industry benchmark for the same timeframe for all US-based project managers and all European-based project managers.
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Questions Performer Can Answer• For My Company, I Want to See
• All performance results for all assessment questions relating to pricing and proposals, including change orders, for CRO 1, 2 and 3.
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Questions Performer Can Answer• For My Company, I Want to See
• Site performance by therapeutic area when the Sponsor selected the sites and when the CRO selected the sites for all studies completed in the past 36 months
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Questions Performer Can Answer• For My Company, I Want to See
• Site performance by therapeutic area when the Sponsor selected the sites and when the CRO selected the sites for all studies completed in the past 36 months
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Q & A
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Special OfferDemo Links
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Thank you