The document discusses how Spaulding Clinical leverages Rave Web Services (RWS) to integrate their phase 1 clinical trials seamlessly with sponsors' Rave electronic data capture (EDC) systems. It describes Spaulding's SCi Rave system, which uses a loader file, extract-transform-load processes, and an interface engine to transfer study data from Spaulding to Rave in near real-time or on scheduled transfers. The system architecture is flexible and has successfully transferred thousands of records across multiple studies with no manual data entry needed. The document concludes by envisioning further integration of devices, sensors and other data sources using systems like RWS.

1. Having
your
Cake
and
Ea1ng
it
Too
–
Leveraging
RWS
with
Phase
1
Studies
Brock Heinz
Spaulding Clinical
March 19, 2013

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. 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. Phase 1 Trial – at a Glance
4

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. 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. Loader file driven design – begin with end in mind
7

8. Data model – driven by Architect Loader

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. 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. SCi Rave – system architecture
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12. Configuring system
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13. Validating ETL; ad hoc interaction
13

14. RWS transactions
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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. 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
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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. Integrated data collection
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19. ECG document – demographics via RWS
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20. Automatic transcription
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21. 21
Thank you!