Reclaiming “Electronic Data Capture" with RWS and

Medical Devices

Brock Heinz Spaulding Clinical16 October 2013

@Brock_Heinz

Brock.Heinz@spauldingclinical.com

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

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

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

Quantified self integration – RWS Integration

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• Support for log lines, transaction inserts and updates

Disruptive Innovator of the Year

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• Co-Presented with Medidata

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Thank you!