WelcomeThank you for joining us

Irina Moissiu, Director Client Relations

Laurie Furiness, EVP Operations & Consulting Services

Sponsor ViewTM

5 Assessments Available

CRO ViewTM

Overview Assessment Available

Patient VoiceTM

Assessments in Development

Available Q1 2016

Site VoiceTM

Assessments in Development

Available Q1 2016

360o SERVICE PERFORMANCE MEASUREMENT

Improve Clinical Trial Efficiency

Avoid Study Delays

Develop Effective Relationship Management

Sponsor

ViewTM

5 Assessments Available

SPONSOR VIEW - FIVE ASSESSMENTS

1- Sales & Contracting

2- Start-up

3- Conduct 4- Closeout

5 – Overall Study

Performance

Statistically Validated

Cloud-based SaaS

Trial-level Actionable Data

In-Trial Alerts and Troubleshooting

Internal and Industry Benchmarking

Quality Performance Indicators (QPI)

Predictive Analytics

A Commitment to Quality, Not A Survey

• Accuracy

• Amendments

• Bid Defense

• Biostatistics

• Case Report Forms

• Central Lab

• Centralized

diagnostic services

• Change Orders

• Clinical Study Plan

• Clinical Study Report

• Clinical Study Team

• Clinical Trials

• Closeout trip report

• Closeout Visits

• Communication

• Communication Plan

• Completeness

• Contracting

• Cost

• CRF

• CRF Tracking

• CTMS

• Data management

• Data Transfer

• Database Lock

• Document Collection

• Drug reconciliation

• Drug returns

• Drug Supply

Management

• EDC

• Endpoints

• Enrollment

• Essential Document

Collection

• Feasibility

• Feasibility

assessment

• Finalizing the report

• First Patient

• First Site

• Forms and

Documents

• GCP/Regulatory

• Imaging

• Initial Proposal

• Investigator Meeting

• Investigator

Recruitment

• Investigators

• IVRS

• Labs

• Last Patient

• Last Site

• Local Lab

• Medical

Management

• Medical writing

• Meeting Criteria

• Monitoring

• Monitors

• Operational Plans

• Post-Trial

Submissions

• Pricing

• Project Manager

• Proposal

• Protocol

• Quality Assurance

• Query

• Query Resolution

• Recruitment

• Regulatory

• Regulatory

Submission

• Resolution

• Retention

• Risk Management

• Safety

• Sales Team

• Senior Management

• Site

• Site Selection

• Sites

• SOP

• SOP Compliance

• Statistical Analysis

• Study Design

• Status Reports

• Study Specific

Conventions

• Study Team

• Sub-contractors

• Tables, figures and

graphs

• Technology

• Training

• Translation

• Trip Reports

• Vendor

Management

• Violations

WHAT WE MEASURE – SERVICE COMPONENTS

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

Project

Mgr Perf

(3)

.98

.95

.96

.97 IP

Skill

6a

6b

6c

6d

.49

.25

.51

.42Know

(4)

5b

5c

.46

5a

HOW WE MEASURE PERFORMANCE

VENDOR MANAGEMENT OPTIONS

OperationalMetrics

SatisfactionSurveys

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

1. Select trials

2. Add trial personnel

3. Assign and send assessments

4. Reporting and analysis

THE FOUR STEPS OF PERFORMER

ASSESSMENT COMPLETION

Link to assessments emailed

3-5 minutes to complete

No proprietary data required

Data Is de-identified

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

IN-TRIAL ALERTS

Internal and External Benchmarking

Quality Performance

Benchmarking

Trial-Level Results

On-Line Reporting

SAMPLE REPORT

SAMPLE FINDINGSFurther 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.

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

QUESTIONS & ANSWERS

Further Contact:

lfuriness@croanalytics.com

imoissiu@croanalytics.com