Presented at Foundry Health's eSource meeting in Chicago, 03-Oct-2017

1. Choosing an eSource System
Daniel Selness

2. What will I be covering?
• About Dan Selness
• About Spaulding Clinical Research
• Who are we talking about
• What are we talking about
• Why eSource
• What you need to look for
• What you need to look out for
• Where is it going
• What does success look and feel like?
• Open Discussion/Questions?

3. Who am I
• Clinical Researcher
• 25 years
• 50/50
• Phase 1
• Phlebotomist to CSO
• Systems Owner2
• Lived through 3 eSource systems

4. Who Is Spaulding Clinical
• ClinSpark User
• Clinical Pharmacology Research Unit
• 200 Beds
• Paperless
• Integrations
• Onsite ECG and Clinical Lab
• FIM/SAD/MAD and TQT/CEQT expertise
• All Phase Cardiac Core Lab
• Full Service Biometrics

5. Who are/were we really talking about?
• Omnicom “TrialOne”
• Instem “AlphaDas”
• Phase 1 Management Systems “PIMs“
• Oracle “LabPass”
• Clinical Ink/Medrio

6. What are we really talking about?
• Subject database
• eSource Data Collection
• Barcode enabled sample management
• Protocol Management Tool
• Electronic signatures/audit trail capabilities (Part 11)
• Device integrations
• Lab/HL-7 integrations
• Remote data review abilities
• Faster, more compliant data export abilities
• End to end operational abilities

7. Why eSource?
• Why not, it is the hot thing everyone is talking about?
• Increased data quality
• Increase protocol compliance
• Real-time data access
• Point of collection data checks
• Increased Sponsor and Monitor satisfaction
• Decreased study start up
• Removal of steps in the data process
• Faster database lock and export datasets

8. What do you need to look for
• Fully operational system (reference sites)
• SDLC and validation support
• Part 11 Compliance
• Implementation assistance
• Scalability
• Hosted vs. cloud based
• System enhancement schedule
• CDISC/ODM compliant
• Internal champions**
• Approach with the end in mind

9. What do you need to look out for
• No reference sites
• Has to be this way
• Internal boat anchors/legacy mindsets
• Overcomplicating things

10. Where is it going?
• eSource usage will grow exponentially over the next 10 years
• Studies will continue to get more complex
• Device integrations get easier
• eSource/EMR integration is the future
• Benefits to big data
• Start up and Close Out timelines will continue to shrink
• Paving way for easier RBM

11. What does success look like?
• Happy staff
• Highly efficient staff
• Data transparency
• Shrinking timelines
• Happy Sponsors
• Happy Monitors
• Availability of performance indicators

12. Thank You!
Open Discussion/Questions?