This document discusses automating the transfer of clinical trial management data from multiple contract research organizations (CROs) into an Oracle Siebel CTMS system. It describes transferring standardized XML files on a regular basis using an XML file transfer utility. This utility automatically retrieves and processes the XML files, performs error checking, and loads the data into the CTMS while logging activity. This allows clinical trial data from multiple CRO partners to be consolidated in a single system.

1. Automatically Retrieving and Loading Data into
Siebel CTMS from Multiple CRO Partners
Param Singh, Director, Clinical Trial Management Solutions, Life Sciences, Perficient
Michelle Engler, Senior Application Architect, Life Sciences, Perficient
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2. About Perficient
Perficient is a leading information technology consulting firm serving clients throughout
North America and Europe.
We help clients implement business-driven technology solutions that integrate business
processes, improve worker productivity, increase customer loyalty and create a more agile
enterprise to better respond to new business opportunities.

3. Perficient Profile
• Founded in 1997
• Public, NASDAQ: PRFT
• 2013 revenue ~$373 million
• Major market locations throughout North America
• Atlanta, Boston, Charlotte, Chicago, Cincinnati, Cleveland,
Columbus, Dallas, Denver, Detroit, Fairfax, Houston,
Indianapolis, Los Angeles, Minneapolis, New Orleans, New
York City, Northern California, Philadelphia, Southern
California, St. Louis, Toronto and Washington, D.C.
• Global delivery centers in China, Europe and India
• >2,100 colleagues
• Dedicated solution practices
• ~85% repeat business rate
• Alliance partnerships with major technology vendors
• Multiple vendor/industry technology and growth awards

4. Life Sciences Practices / Solutions
Deep Clinical and Pharmacovigilance Applications Expertise
Implementation
Migration
Integration
Validation
Consulting
Upgrades
Managed Services
Application Development
Private Cloud Hosting
Application Support
Sub-licensing
Study Setup
Services
Clinical Trial
Management
Clinical Trial Planning and Budgeting
Oracle ClearTrial
CTMS
Oracle Siebel CTMS / ASCEND
Mobile CRA
Clinical Data Management
& Electronic Data Capture
CDMS
Oracle Clinical
Electronic Data Capture
Oracle Remote Data Capture
Oracle InForm
Medical Coding
Oracle Thesaurus Management System
Safety &
Pharmacovigilance
Adverse Event Reporting
Oracle Argus Safety Suite
Oracle AERS / EmpiricaTrace
Axway Synchrony Gateway
Signal Management
Oracle Empirica Signal/Topics
Medical Coding
Oracle Thesaurus Management System
Clinical Data
Warehousing & Analytics
Clinical Data Warehousing
Oracle Life Sciences Data Hub
Clinical Data Analytics
Oracle Clinical Development Analytics
JReview
Data Review and Cleansing
Oracle Data Management Workbench
Clients

5. Welcome & Introduction
Param Singh
Director of Clinical Trial Management Solutions
Life Sciences, Perficient
Michelle Engler
Senior Solutions Architect
Life Sciences, Perficient

6. Agenda
• CRO to Siebel CTMS integration business case
• Types of data for integration
• Standard XML format and EOT files
• Automating the synchronization process
• XML File Transfer Utility
– Configuration
– Workflow
– Error checking and handling
– Logging and notification
• Integration process in action (short video)
• Lessons learned
• Questions
• Contact Information

7. CRO to Siebel CTMS
Integration Business Case
• Industry trends
– General increase costs of drug development
– Over 70% of cost in R&D are related to clinical trials
• Ways to reduce costs
– Implement technology solutions
– Outsource
• Outsourcing trends
– Overall increase spend on CRO services
• $9.8 billion in 2001
• $15 billion in 2007
• $24 billion in 2010
• Increasingly important role of CROs results in need for greater
collaboration between sponsors and CROs

8. CRO to Siebel CTMS
Integration Business Case
• Current Client Scenario
– Moving to 100% outsourced model
– Have identified 3 preferred CRO partners (various systems)
– Receive regular reports from these partners
– Reports from each vendor are different and hard to consolidate and
generate metrics
• Client Needs
– Need to have central repository of all CTMS data
• Implemented Siebel CTMS
– Needs to standardize reports and metrics for all studies
– Need to be able to view consolidated data in timely manner to
support real time decisions
– Need to minimize or eliminate data entry for CTMS data managed
by CRO

9. Benefits of CRO Integration
Benefits
• Scalable solution
– No need to train CRO personnel on in house CTMS use; CRO
resources can scale up, scale down or change as needed
without impacting data sharing
– If designed in standard format, can be used with as many CROs
as desired
• Saves time otherwise spent on data entry, data conversions,
etc.
• Ensures higher data quality across all studies and integrated
CRO partners
• Automatically checks for errors; sends notifications when
found
• Provides clean data to sponsor as quickly as desired
– Interface schedule is determined by sponsor

10. Overall Integration Flow

11. Types of Data for Integration
This CRO integration takes into account the majority of the data entry
within CTMS. The only requirement is that the protocol and region level
are already setup in CTMS. The following data is automatically imported:
– Address
– Account
– Contact
– Site
– Site Address
– Site Accounts
– Site Contacts
– Site Activities
– Site Document
– Site Protocol Deviation
– Site Visits
– Subjects
– Subject Visits & CRF
– Subject Adverse Events

12. Standard XML Format and EOT Files
• Each XML file expected from each CRO has a standard format and
standard naming convention so the integration can identify it.
• Components of file name
– DateTime – Identifies the date/time of file extract
– Seq # - Identifies the type of data object
– CRO ID –Identifies from which CRO this file originated
– Protocol # - Identifies the study # in CTMS
• Layout of each XML file
– Prescribed XSD (extensible schema definition) for each data object,
inclusive of prescribe tag name, and expected values
• EOT file – end of transfer file (fail safe)
– Lists all files transferred with each extract
– Indicates that transfer of files is complete
– If EOT file is not there, or XML file listed in EOT is not listed, system
will generate an error

13. Automating the Synchronization Process:
Overall Process
CRO1
CRO2
CRO3
File Movement
SFTP Folders
Client Siebel
XML Folders
INTEGRATION_LOG
Table list the xml files to
process by workflow in
the sequence
Load log table
Call res pec tive
workflow
Siebel
Workflow
Select next
record to
process
Read table to
Process next record
Siebel
Workflow
Read File &
Call Siebel
business
service
ReadXML File
XML Transfer
Automation Utility
Diagram 1: Interface data flow for CRO Studies
Sys tem Admin updates Accounts /Contact/Address in Siebel
CTMS
Load to CTMS
p1

14. Slide 13
p1 Not sure if you want this here? or you want something else here that speask to the details of the process of the XML Tranfers
Automation utility itself.
psingh, 6/3/2014

15. XML Transfer Automation Utility
Configuration
• Configuration file drives the
XML Transfer Automation Utility
• Allows for configuration of
items such as:
– Database Connection Settings
– Email SMTP Settings
– sFTP Server Settings
– CRO sFTP Path
– CRO Local Path
– CRO Archive Path
• Uses encrypted passwords
• Configuration allows multiple
CROs to be handled
simultaneously

16. XML Transfer Automation Utility
Workflow
Scheduler
Read
Configuration
Items
No Yes
Error checking: Were
errors found?
Stop processing EOT
and referenced XML
files (rollback)
New CRO to
process?
New EOT files for
CRO?
Send Notification
No Email
Errors
found
Retrieve EOT and XML Files
from sFTP to Local Directory
Register Files
with Siebel
Clinical
Copy files to archive
directory
Clean old files from
archive directory
No Errors
Error checking: Were
errors found?
No Errors
Error checking: Were
errors found?
No Errors
Errors found
Errors found

17. XML Transfer Automation Utility
Error Checking
• Infrastructure Checking
– Was a connection to the database able to be established?
– Was a connection to the sFTP server able to be established?
– Do the referenced sFTP, local, and archive directories exist?
• EOT and XML File Checking
– Are all the XML files listed in the EOT present on the ftp server?
– Are the XML files included for expected data items?
• Transfer Success Checking
– Was the EOT and related XML files partially processed before and
existing in the local directory already?
– Were the EOT and XML files able to be retrieved?
• Registration Checking
– Were the EOT and XML files able to be registered with SC?
– Could the EOT and XML files be copied to the archive directory?

18. XML Transfer Automation Utility
Error Handling
• If infrastructure checking returns error, log error and exit program
• If EOT and XML file checking returns error, stop processing EOT,
log error, move on to the next EOT
• If transfer success checking returns error, stop processing EOT,
log error, move on to the next EOT
• If registration checking returns error, stop processing EOT,
remove locally copied files, log error, move on to next EOT
• If no errors found in processing:
– Log EOT processing success
– Copy files to archive directory
– Clean archive directory of old files
– Remove EOT and XML from sFTP Server
– Move on to next EOT

19. XML Transfer Automation Utility
Logging and Notification
• Send summary email to administrator (if set in
configuration)
• Send error information to administrator in case
of any failures
• Keep a detailed log of processing actions

20. Integration Process In Action
Demonstration

21. Lessons Learned
• Configurability of the system was critical
– Configuration input file
– Ability to setup system for multiple CRO sources
– Ability to control features of the system
– Connection information
• Communication documentation between team members
– Clearly defined requirements
– Development meeting to go over requirements
– System/technical design specification
• Design of system to capture error conditions and rollback
– EOT files ensured processing of XML data would not occur until the
initial transmission was complete
– Checking file sizes, number of expected files per EOT, and whether
files had been transferred before allowed for a high level of confidence
• Automatic notification allows for the system to be run hands off

22. Questions?

23. Thank You!
For more information, please contact:
Param.Singh@perficient.com
Michelle.Engler@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+1 303 570 8464 (U.S. Sales)
+44 (0) 1865 910200 (U.K. Sales)
www.perficient.com
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