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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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.

About Perficient

• 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

Perficient Profile

Life SciencesPr

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tions

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Integration

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Managed ServicesApplication Development

Private Cloud Hosting

Application SupportSub-licensingStudy Setup

Services

Deep Clinical and Pharmacovigilance Applications Expertise

Clinical TrialManagement

Clinical Trial Planning and BudgetingOracle ClearTrial

CTMSOracle Siebel CTMS / ASCEND

Mobile CRA

Clinical Data Management & Electronic Data Capture

CDMSOracle Clinical

Electronic Data CaptureOracle Remote Data Capture

Oracle InForm

Medical CodingOracle Thesaurus Management System

Safety &Pharmacovigilance

Adverse Event ReportingOracle Argus Safety Suite

Oracle AERS / EmpiricaTraceAxway Synchrony Gateway

Signal ManagementOracle Empirica Signal/Topics

Medical CodingOracle Thesaurus Management System

Clinical DataWarehousing & Analytics

Clinical Data WarehousingOracle Life Sciences Data Hub

Clinical Data AnalyticsOracle Clinical Development Analytics

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Data Review and CleansingOracle Data Management Workbench

Clients

Welcome & Introduction

Param SinghDirector of Clinical Trial Management SolutionsLife Sciences, Perficient

Michelle EnglerSenior Solutions ArchitectLife Sciences, Perficient

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

CRO to Siebel CTMSIntegration 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

CRO to Siebel CTMSIntegration 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

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

Overall Integration Flow

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

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

Automating the Synchronization Process: Overall Process

CRO1

CRO2

CRO3

File Movement

SFTP Folders

Client Siebel XML Folders

IN TEGRATION_LOGTable list the xml files to process by workflow in

the sequenceLoad log table

Call respec tive workf low

Siebel Workflow

Select next record to process

Read table toProcess next record

Siebel Workflow

Read File & Call Siebel business service

Read XML File

XML Transfer Automation Ut ility

Diagram 1: Interface data flow for CRO Studies

System Admin updates Accounts /Contact/Address in Siebel

CTMS

Load to CTMS p1

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

XML Transfer Automation UtilityConfiguration

• 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

XML Transfer Automation UtilityWorkflow

SchedulerRead 

Configuration Items

Error checking: Were errors found?

Stop processing EOT and referenced XML 

files (rollback)

New CRO to process?

New EOT files for CRO?

No Yes

Send Notification  EmailNo

Errorsfound

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

XML Transfer Automation UtilityError 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?

XML Transfer Automation UtilityError 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

XML Transfer Automation UtilityLogging 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

Integration Process In Action

Demonstration

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

Questions?

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Thank You!For more information, please contact:

Param.Singh@perficient.comMichelle.Engler@perficient.com

LifeSciencesInfo@perficient.com (Sales)+1 303 570 8464 (U.S. Sales)

+44 (0) 1865 910200 (U.K. Sales)