Welcome. Thank you for joining us. Irina Moissiu, Director Client Relations Laurie Furiness, EVP Operations & Consulting Services

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2 Welcome Thank you for joining us Irina Moissiu, Director Client Relations Laurie Furiness, EVP Operations & Consulting Services

3 360 o SERVICE PERFORMANCE MEASUREMENT Sponsor View TM 5 Assessments Available CRO View TM Overview Assessment Available Patient Voice TM Assessments in Development Available Q Site Voice TM Assessments in Development Available Q1 2016

4 Sponsor View TM 5 Assessments Available Improve Clinical Trial Efficiency Avoid Study Delays Develop Effective Relationship Management

5 SPONSOR VIEW - FIVE ASSESSMENTS 1- Sales & Contracting 2- Start-up 3- Conduct 4- Closeout 5 Overall Study Performance

6 A Commitment to Quality, Not A Survey Statistically Validated Cloud-based SaaS Trial-level Actionable Data In-Trial Alerts and Troubleshooting Internal and Industry Benchmarking Quality Performance Indicators (QPI) Predictive Analytics

7 WHAT WE MEASURE SERVICE COMPONENTS Accuracy Contracting Feasibility Local Lab Regulatory Conventions Amendments Bid Defense Biostatistics Case Report Forms Cost CRF CRF Tracking CTMS Feasibility assessment Finalizing the report First Patient Medical Management Medical writing Meeting Criteria First Site Monitoring Central Lab Data management Forms and Monitors Centralized Data Transfer Documents diagnostic services Operational Plans Database Lock GCP/Regulatory Change Orders Post-Trial Document Collection Imaging Submissions Clinical Study Plan Drug reconciliation Initial Proposal Pricing Clinical Study Report Drug returns Investigator Meeting Project Manager Clinical Study Team Drug Supply Investigator Proposal Clinical Trials Management Recruitment Protocol Closeout trip report EDC Investigators Quality Assurance Closeout Visits Endpoints IVRS Query Communication Enrollment Labs Query Resolution Communication Plan Essential Document Last Patient Collection Recruitment Completeness Last Site Regulatory Submission Resolution Retention Risk Management Safety Sales Team Senior Management Trip Reports Site Site Selection Sites SOP SOP Compliance Statistical Analysis Study Design Status Reports Study Specific Study Team Sub-contractors Tables, figures and graphs Technology Training Translation Vendor Management Violations

8 WHAT WE MEASURE SKILL COMPONENTS Adaptability Budgeting Clarity Collaboration Communication Comprehension Deadlines Effectiveness Efficiency Fairness General Knowledge Management Meeting Expectations Meeting Management Planning Proactive Problem-Solving Professionalism Reliability Responsiveness Retention Speed Team Alignment Timeliness Training Understanding of the Study

9 HOW WE MEASURE PERFORMANCE 5a.25 5b 5c Know (4).46 Project Mgr Perf (3).49 6a.96 6b 6c 6d.97 IP Skill.95.98

10 VENDOR MANAGEMENT OPTIONS Operational Metrics Satisfaction Surveys Measures Performance Quality Real-Time Data Statistically Validated Response Rate >80% n/a <15% Rapid Root Cause Analysis Predictive Analytics On-Line Dashboard Sub-Contractor Tracking Benchmarking

11 THE FOUR STEPS OF PERFORMER 1. Select trials 2. Add trial personnel 3. Assign and send assessments 4. Reporting and analysis

12 ASSESSMENT COMPLETION Link to assessments ed 3-5 minutes to complete No proprietary data required Data Is de-identified

13 IN-TRIAL ALERTS Continuous in-trial monitoring of submitted assessments Alert triggers can be customized by: therapeutic area trial performance drivers functional area professional skill sets Customized communication protocols Resolution support available

14 On-Line Reporting Internal and External Benchmarking Quality Performance Benchmarking Trial-Level Results

15 SAMPLE REPORT

16 SAMPLE FINDINGS Further drilldown on low scores revealed Vendor s ability to Offer Effective Solutions Vendor s ability to demonstrate Knowledge in Therapeutic Area Observations information distributed to various vendors timelines given to vendors to respond to RFP information contained within the RFP answers provided to vendors who have FU questions way in which vendors are selected to receive the RFP Recommend: The outsourcing team should review their own internal process and request feedback from all the vendors who received the RFP. That feedback should guide them as to where they can improve their process.

17 In Summary: Reduce Delays and Budgets Faster, More Accurate Root-Cause Analysis Immediate drill-down on factors impacting performance Valid, reliable, and accessible data create quicker consensus Data-Driven Research Relationships Strengthen partnerships via transparency and accountability Prioritize operational process improvement Enhances the utility of KPIs/Metrics

18 QUESTIONS & ANSWERS Further Contact: