EMUG 2013 Presentation
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Reclaiming “Electronic Data Capture" with RWS and
Medical Devices
Brock Heinz Spaulding Clinical16 October 2013
@Brock_Heinz
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About me and Spaulding Clinical Research
• Brock Heinz - Engineering / Innovation; successfully demoted; introduced to Medidata in 2009; Technology Partner
• 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
• Highly integrated and automated phase I clinical pharmacology research unit; 155 beds – 96 telemetry
• Data Management, Biostatistics and Medical Writing Services
• Full Service Core ECG Lab
• Medical Device Manufacturer
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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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Phase 1 Trial – at a Glance
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SCi Rave – system architecture; presented at AMUG ‘13
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Spaulding webECGTM
• Hand-held diagnostic electrocardiograph uploads data to web-based ECG Management System
• Biometric voice ID eliminates demographic entry errors
• Single button allows for malleable user interface
• Stores up to 5 minutes of 12-lead ECG data • Automated report available immediately
• Nearly instant over-reading
Model 1000iQ Electrocardiograph
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Integrated data collection
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ECG document – demographics via RWS
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Automatic transcription
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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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Quantified self integration
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Quantified self integration
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Integrates with Fitbit, Withings, Nike, and Jawbone UP
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Quantified self integration – RWS Integration
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• RWS settings available in web interface• Allows for automated seamless transfers• Poll cycles and real-time supported
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Quantified self integration – RWS Integration
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• Support for log lines, transaction inserts and updates
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Disruptive Innovator of the Year
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• Co-Presented with Medidata
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Thank you!