Integration of ePro by Sheila Rocchio, MBA

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The Integration of ePRO with other eClinical Systems A review of what sponsors and sites need to know about ePRO, including the multiple types of ePRO systems, the history and rationale for using ePRO, and the integration of ePRO with other eClinical systems.

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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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