EMUG 2013 Presentation

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Presentation given 16 October 2013 in Florence, Italy at the Medidata EMUG: http://www.mdsol.com/conferences/mug/emug.html

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EMUG 2013 Presentation

  1. 1. Reclaiming “Electronic Data Capture" with RWS and Medical Devices Brock Heinz Spaulding Clinical 16 October 2013 @Brock_Heinz Brock.Heinz@spauldingclinical.com
  2. 2. About me and Spaulding Clinical Research • • 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 • 2 Brock Heinz - Engineering / Innovation; successfully demoted; introduced to Medidata in 2009; Technology Partner Medical Device Manufacturer
  3. 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 3
  4. 4. Phase 1 Trial – at a Glance 4
  5. 5. SCi Rave – system architecture; presented at AMUG ‘13 5
  6. 6. 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
  7. 7. Integrated data collection 7
  8. 8. ECG document – demographics via RWS 8
  9. 9. Automatic transcription 9
  10. 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? 10
  11. 11. Quantified self integration 11
  12. 12. Quantified self integration Integrates with Fitbit, Withings, Nike, and Jawbone UP 12
  13. 13. Quantified self integration – RWS Integration • RWS settings available in web interface • Allows for automated seamless transfers • Poll cycles and real-time supported 13
  14. 14. Quantified self integration – RWS Integration • Support for log lines, transaction inserts and updates 14
  15. 15. Disruptive Innovator of the Year • Co-Presented with Medidata 15
  16. 16. Thank you! 16
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