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: