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Sheila Rocchio Vice President, Marketing & Product Management 617.973.1666 Fax/Mobile [email_address] March 11, 2009 Electronic Data in Clinical Trials  Integrating Electronic Patient Reported Outcomes with other eClinical Data Streams See what’s new at the award-winning  phtcorp.com
Discussion Topics ,[object Object],[object Object],[object Object],[object Object],Today’s Speakers
Definitions  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Available ePRO Platforms  ,[object Object],[object Object],[object Object],[object Object]
Reasons for Integrating eClinical Data  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study: Rescue Medication ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study: Rescue Medication (Continued)  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study Participants  ePRO Vendor CRO EDC Vendor Sponsor Diary Data Rescue Medication Intake Merged Data Rescue Medication Details
Case Study #2: Eligibility Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study #2: Eligibility Criteria (continued)  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study #3: Adaptive Trial Design for Migraine Study ,[object Object],Subject with Qualifying Headache eDiary System Adaptive Algorithm IVRS
Case Study #3: Adaptive Trial Design for Migraine Study Subject eDiary Adaptive Algorithm IVRS 1. Subject Call 2. Dose Regimen Code 3. Enter Dose Regimen Code 4. Dose Regimen revealed 5.  Treat headache; complete post-dose assessments 6. Two-hour time point data used to update Adaptive Algorithm weekly 7.  Update randomization boundaries
Case Study #3: Adaptive Trial Design for Migraine Study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Example
Case Study #3: Adaptive Trial Design (continued)  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study #4: Peak Flow Meter Integration  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study #4: Peak Flow Meter Integration (continued)  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Integration Considerations and Best Practices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Thank you for your time! Questions?  Sheila Rocchio 617.973.1666 [email_address]

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Integration of ePro by Sheila Rocchio, MBA

  • 1. Sheila Rocchio Vice President, Marketing & Product Management 617.973.1666 Fax/Mobile [email_address] March 11, 2009 Electronic Data in Clinical Trials Integrating Electronic Patient Reported Outcomes with other eClinical Data Streams See what’s new at the award-winning phtcorp.com
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8. Case Study Participants ePRO Vendor CRO EDC Vendor Sponsor Diary Data Rescue Medication Intake Merged Data Rescue Medication Details
  • 9.
  • 10.
  • 11.
  • 12. Case Study #3: Adaptive Trial Design for Migraine Study Subject eDiary Adaptive Algorithm IVRS 1. Subject Call 2. Dose Regimen Code 3. Enter Dose Regimen Code 4. Dose Regimen revealed 5. Treat headache; complete post-dose assessments 6. Two-hour time point data used to update Adaptive Algorithm weekly 7. Update randomization boundaries
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18. Thank you for your time! Questions? Sheila Rocchio 617.973.1666 [email_address]

Notes de l'éditeur

  1. (Personalized intro’s and thank you for your time)