This document discusses Spaulding Clinical's approach to electronic data capture (EDC) in phase 1 clinical trials using Real World Solutions (RWS) and medical devices. Key points: 1) Spaulding Clinical uses fully integrated EDC where data is captured electronically from the source (e.g. ECG, vitals, labs) rather than later entered, ensuring accurate and timely data collection. 2) Their approach aims to maximize automation so computers perform routine tasks, while humans focus on patient-centered work. 3) Spaulding is developing technologies like a hand-held ECG device that uploads securely to their system, eliminating errors from manual data entry.

1. Reclaiming “Electronic Data
Capture" with RWS and
Medical Devices
Brock Heinz
Spaulding Clinical
16 October 2013
@Brock_Heinz
Brock.Heinz@spauldingclinical.com

2. About me and Spaulding Clinical Research
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Established in 2007 with a team of experts from pharmaceutical,
CRO, clinical practice, and the medical device industries with over
150 years of combined experience; Located in West Bend, WI – 30
miles north of Milwaukee
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Highly integrated and automated phase I clinical pharmacology
research unit; 155 beds – 96 telemetry
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Data Management, Biostatistics and Medical Writing Services
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Full Service Core ECG Lab
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Brock Heinz - Engineering / Innovation; successfully demoted;
introduced to Medidata in 2009; Technology Partner
Medical Device Manufacturer

3. Phase 1 trials at Spaulding Clinical
• EDC true to the acronym: truly using electronic means for
data capture; not just electronic storage
• Barcode-driven data collection – right subject each time
• Integration of ECG, vitals, labs
• Rapid data lock is the rule, not the exception
• Data cleaning is a dirty term
• Sponsors always have real time access to study data
• Basic philosophy I’ve helped instill – let computers do what
computers are good at, thus maximizing the human touch
• Computers consistently do the right thing at the right time
• Humans work well with humans – keep the peace with
subjects
• Reducing variability is good science
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4. Phase 1 Trial – at a Glance
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5. SCi Rave – system architecture; presented at AMUG ‘13
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6. Spaulding webECGTM
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Hand-held diagnostic electrocardiograph uploads
data to web-based ECG Management System
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Biometric voice ID eliminates demographic entry
errors
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Single button allows for malleable user interface
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Stores up to 5 minutes of 12-lead ECG data
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Automated report available immediately
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Nearly instant over-reading
Model 1000iQ
Electrocardiograph

7. Integrated data collection
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8. ECG document – demographics via RWS
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9. Automatic transcription
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10. What’s next?
• How do we engage patients in a way that will help to lead to
better outcomes?
• How can this be done in an integrated fashion?
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11. Quantified self integration
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12. Quantified self integration
Integrates with Fitbit, Withings, Nike, and Jawbone UP
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13. Quantified self integration – RWS Integration
• RWS settings available in web interface
• Allows for automated seamless transfers
• Poll cycles and real-time supported
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14. Quantified self integration – RWS Integration
• Support for log lines, transaction inserts and updates
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15. Disruptive Innovator of the Year
• Co-Presented with Medidata
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16. Thank you!
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