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Medidata AMUG Meeting / Presentation 2013


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The slide deck from my presentation from March 2013

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Medidata AMUG Meeting / Presentation 2013

  1. 1. Having  your  Cake  and  Ea1ng  it   Too  –  Leveraging  RWS  with   Phase  1  Studies   Brock Heinz Spaulding Clinical March 19, 2013
  2. 2. 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 2  
  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. What’s the Cake? •  The cake in this context is a paperless and and automated Phase 1 study seamlessly integrated with the sponsor’s EDC system of choice – Rave Who’s Cake is it? •  Sponsors who have a desire to maintain study data throughout the lifecycle of a compound in Rave 5  
  6. 6. How can one have their cake and eat it too? Introducing SCi Rave (pronounced sky) •  The customer is always right. Sponsors understand their data structures and their processes, data standards come from the top down. •  Modular system consists of three major components •  Rave – where are we going? •  ETL – how / what should we pack? •  Interface Engine – how do we get there? •  Process Overview •  Upload / parse loader file •  Develop / validate ETL •  Schedule and execute transfers 6  
  7. 7. Loader file driven design – begin with end in mind 7  
  8. 8. Data model – driven by Architect Loader
  9. 9. ETL – packing for the trip •  Extract, Transform, Load •  Incredibly flexible model – layer of indirection can obtain data from other EDC systems, relational databases, flat files, etc •  Two primary tasks: –  Identify subjects –  Query study repository(ies?) and populate tables created by loader parsing process •  Script is uploaded through our web interface and is compiled and executed on the server •  Validate ETL script! –  Pre-transferred data can be reviewed in Excel / CSV 9  
  10. 10. Let’s go! Scheduling and executing the transfer •  Transfer schedule is flexible – can be dictated by sponsor •  Designate transfer schedule –  Automatic and near real-time –  Ad hoc •  Transfer schedule set from web interface •  Subjects inserted, form (Item Group) data sent •  Each transaction response from RWS is stored with the Item Group for which it was sent; available for review in web dashboard 10  
  11. 11. SCi Rave – system architecture 11  
  12. 12. Configuring system 12  
  13. 13. Validating ETL; ad hoc interaction 13  
  14. 14. RWS transactions 14  
  15. 15. Memories of a recent trip •  3 studies conducted in rapid succession •  3,926 Folders •  18,803 Forms •  54,039 Item Groups (includes log lines) •  322,685 Items •  1,460,485 characters of time-point data •  78,796 HTTPS Requests to RWS •  0 CRFs manually transcribed from the Spaulding Clinical system into Rave 15  
  16. 16. Final thoughts I’ve been around web services for a while – this is well done: ODM, interoperable protocols, intuitive response messages, documentation, user group, etc. As leaders in EDC Medidata is refreshingly different than EMR vendors. What’s next? •  I think we’ll seen see an evolution of drug development process. There will be disruption as there is a push towards personalized medicine. Tighter iterations, richer data. •  Big Data – sensors; distributed telemetry; integrated data repositories. Mobile integration. •  Empower innovators – RWS gives us the highway needed. •  Device level integration - today 16  
  17. 17. 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
  18. 18. Integrated data collection 18  
  19. 19. ECG document – demographics via RWS 19  
  20. 20. Automatic transcription 20  
  21. 21. 21   Thank you!