Transcript Moving from Paper to EDC: A CRO Perspective

Moving from Paper to EDC: A
CRO Perspective
Presented at
– eTrials User Conference, Orlando Fl,
2005
– Eastern Technology Council, Malvern,
PA, 2006
– Clinical Trials Congress, Orlando, FL,
2006
– EDC and Beyond, Las Vegas, NV 2006
Moving from Paper to EDC:
CRO Perspective
• Status
• Moving Forward
– Paradigm shifts
– Budget/pricing
etrials/OCR Status
• Partnership Agreement: April 05
• Tech Transfer: January 06
Key:
Begin with a Simple Study
Our First Study
• 7,633 Patients
• 613,000 eCRF Pages
• 15 Countries, 4 Continents
• 222 Total Users; 168 at Peak
– < 2 second page turn
– 4 load-balanced servers
• Ramp-up: 3 Weeks
• All Entry Within 28 Days
Lessons Learned
• Big Confidence Booster
• Confirmed Relationship Issue
• Training Perspective
• Communication Disconnect
Communication: Not Good
Sponsor
EDC
CRO
Communication: Good
Sponsor
• One CDM/eCDM Leader
• Charter
EDC
CRO
Different Acronyms/
Different Systems
• EDC
– Entry/cleaning at sites
• eClinical
– Multidisciplinary ongoing, real-time
access to study data
Paradigm: PM Role
• Tasks
– Communicate trial progress
– Finances
Trial Management
• New Skill Set; Higher Level Tasks
• Steering Committee Option
– eClinical webcasts
vs.
Fixed project team meetings
– Real-time problem solving
eClinical and CTMS
Study
Data
Site, Investigator
Data
Monitoring
• “20% Reduction”
• Reduce Travel Costs
• Less Query Work at Sites
• “100%” SDV not ICH, GCP
Requirement
CRF
eSource
• Useful To
– Pre-populate eCRF
– Pull from EMR?
• Should Think About
– Data integration
– Need for data reduction
Data
Source(s)
Clinical DB
SAS
Analysis DB
CSR
Data
Source(s)
Clinical DB
SAS
Analysis DB
CSR
“Other
Stuff”
DB
CRO Pricing
• Our System
• Your System
• Paper
Training
• High Level Overview
• Specific to Function
• Webcasts for Current
eClinical Projects
Other Issues
• Coding at Sites
• 2nd Pass Entry
• Rethink/Rebuild Processes
– Do not: Retrofit old paper processes
to eClinical
– Do: Modify processes to embrace full
potential of eClinical
Conclusion
• eClinical: Better with Less Time
and Less People = Less Cost
• Reduce: Trial Cost Drivers
– Monitoring
– PM
– DM
• Increase: Value Added Trial
Management
CRO Expectations
• eClinical: Better with Less Time
and Less People = Less Cost
• Reduce: Trial Cost Drivers
– Monitoring
– PM
– DM
• Increase: Value Added Trial
Management