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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

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: performer@croanalytics.com

• 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

Thank you