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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

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Moving from Paper to EDC: A CRO Perspective

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  1. 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

  2. Moving from Paper to EDC:CRO Perspective • Status • Moving Forward • Paradigm shifts • Budget/pricing

  3. etrials/OCR Status • Partnership Agreement: April 05 • Tech Transfer: January 06

  4. Key: Begin with a Simple Study

  5. 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

  6. Lessons Learned • Big Confidence Booster • Confirmed Relationship Issue • Training Perspective • Communication Disconnect

  7. Sponsor EDC CRO Communication: Not Good

  8. One CDM/eCDM Leader • Charter Communication: Good Sponsor EDC CRO

  9. Different Acronyms/Different Systems • EDC • Entry/cleaning at sites • eClinical • Multidisciplinary ongoing, real-time access to study data

  10. Paradigm: PM Role • Tasks • Communicate trial progress • Finances

  11. Trial Management • New Skill Set; Higher Level Tasks • Steering Committee Option • eClinical webcasts • vs. • Fixed project team meetings • Real-time problem solving

  12. Site, Investigator Data Study Data eClinical and CTMS

  13. Monitoring • “20% Reduction” • Reduce Travel Costs • Less Query Work at Sites • “100%” SDV not ICH, GCP Requirement

  14. CRF eSource • Useful To • Pre-populate eCRF • Pull from EMR? • Should Think About • Data integration • Need for data reduction

  15. Clinical DB Data Source(s) SAS Analysis DB CSR

  16. Clinical DB Data Source(s) “Other Stuff” DB SAS Analysis DB CSR

  17. CRO Pricing • Our System • Your System • Paper

  18. Training • High Level Overview • Specific to Function • Webcasts for Current eClinical Projects

  19. Other Issues • Coding at Sites • 2nd Pass Entry

  20. Rethink/Rebuild Processes • Do not: Retrofit old paper processes to eClinical • Do: Modify processes to embrace full potential of eClinical

  21. Conclusion • eClinical: Better with Less Time and Less People = Less Cost • Reduce: Trial Cost Drivers • Monitoring • PM • DM • Increase: Value Added Trial Management

  22. CRO Expectations • eClinical: Better with Less Time and Less People = Less Cost • Reduce: Trial Cost Drivers • Monitoring • PM • DM • Increase: Value Added Trial Management

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