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
EDC CRO
• One CDM/eCDM Leader
• Charter
• EDC– Entry/cleaning at sites
• eClinical– Multidisciplinary ongoing, real-time
access to study data
Different Acronyms/Different Systems
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
StudyData
Site, InvestigatorData
eClinical and CTMS
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
Clinical DB
SAS
Analysis DB
Data
Source(s)
CSR
Data
Source(s)
“Other Stuff”
DBClinical DB
SAS
Analysis DB
CSR
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
• eClinical: Better with Less Time
and Less People = Less Cost
• Reduce: Trial Cost Drivers– Monitoring– PM– DM
• Increase: Value Added Trial Management
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
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