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CRO Analytics provides the only validated performance data collection system, providing straightforward access to reliable benchmarking, key performance drivers and predictive analytics in an intuitive format. Our assessment tools and services make clinical research better, faster and less expensive.
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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
5/15/2014 2
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
5/15/2014 3
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
5/15/2014 4
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
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
5/15/2014 49
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
5/15/2014 52
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
5/15/2014 53
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
Thank you