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. Communication: Not Good Sponsor EDCCRO

8. Communication: Good Sponsor EDCCRO One CDM/eCDM Leader Charter

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

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. Study Data Site, Investigator Data eClinical and CTMS

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

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

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

16. Data Source(s) Other Stuff DB Clinical 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. eClinical: Better with Less Time and Less People = Less Cost Reduce: Trial Cost Drivers –Monitoring –PM –DM Increase: Value Added Trial Management Conclusion

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