Optimizing Siebel CTMS with Electronic Trip Reports

Param Singh, Director of Clinical Trial Management SolutionsLife Sciences Business Unit

facebook.com/perficient twitter.com/perficient_LSlinkedin.com/company/perficient

Welcome & Introduction

Param SinghDirector of Clinical Trial Management SolutionsLife Sciences, Perficient

• CTMS practice head since 2008– Leads the team that implements, supports, enhances and

integrates Oracle’s CTMS solution

• Extensive Siebel CTMS implementation experience– 14+ years of experience implementing Siebel CTMS

– 30+ implementations and integrations

– Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for Siebel CTMS

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

BUSINESS SOLUTIONSBusiness IntelligenceBusiness Process ManagementCustomer Experience and CRMEnterprise Performance ManagementEnterprise Resource PlanningExperience Design (XD)Management Consulting

TECHNOLOGY SOLUTIONSBusiness Integration/SOACloud ServicesCommerceContent ManagementCustom Application DevelopmentEducationInformation ManagementMobile PlatformsPlatform IntegrationPortal & Social

Our Solutions Expertise

Life SciencesPr

actic

es /

Solu

tions

ImplementationMigration

Integration

ValidationConsultingUpgrades

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

JReview

Data Review and CleansingOracle Data Management Workbench

Clients

Welcome & Introductions

CTMS Practice Services

ImplementationManage implementations of Siebel CTMS/ASCEND and Mobile CRA.

IntegrationBuild interfaces between Siebel CTMS and other clinical and safety systems.

TrainingDevelop and/or deliver standard and custom training classes and materials.

Process GuidanceProvide insight, advice and solutions for specific CTMS issues based on industry best practices.

Today’s Agenda

Time Topic1:00‐1:05 Welcome and Introductions1:05‐1:10 Components of Trip Reports1:10‐1:25 Common Trip Report Challenges

• Adhere to SOPs• Capture Snapshot in Time• Track Throughout Review Process• Record Compliant Approvals

1:25‐1:45 Live Demo of Trip Report Completion & Approval in Siebel CTMS ASCEND

1:45‐2:00 Q&A

Trip Report Components

• Site visit information• Checklist items• Narrative questions• Follow-up items• Additionally, for monitoring visits:

o Enrollment statisticso Serious Adverse Events (SAEs)o Protocol Deviations (PDs)o Monitored Case Report Forms (CRFs)

Trip Report Components

• Site visit informationo Protocolo Site #o PI Nameo Location/Site Nameo Visit Typeo Visit Start Dateo Visit End Dateo Visit Statuso Attendees

Trip Report Components

• Checklist items (yes/no)o Site staff training records are current.o Site regulatory binder is complete.o Each informed consent form is countersigned

and dated.o Investigational product is being stored

appropriately.o Investigational product supply is adequate for

anticipated enrollment.

Trip Report Components

• Narrative questions (open-ended)o How would you describe the site's compliance

with the informed consent policy?o How would you describe the site's compliance

with the drug accountability procedure?o How would you describe the site’s overall

management of study-related documentation?

Trip Report Components

• Follow-up itemso Sub-I requires training in product handlingo New microscope needs to be set upo Need to obtain CDA from new staff nurseo No Internet access availableo Investigational product is not being stored in

proper conditions

Trip Report Components

• Additionally, for monitoring visits:o Enrollment statistics

o Current at time of visito Serious Adverse Events (SAEs)

o Monitored during visito Protocol Deviations (PDs)

o Monitored during visito Monitored Case Report Forms (CRFs)

o Monitored during visit

Trip Report Challenges

• Adhere to site visit SOPs• Capture a snapshot in time for when the

site visit occurred• Track the report throughout the review

process• Record compliant approvals

Adhere to SOPs

Siebel Clinical template functionalityo Allows an administrator to create an outline, or

template, of each type of site visit - usually qualification, initiation, monitoring and close-out

o Templates can be set up to mirror SOPso Templates can be applied over and over for

each site visit to ensure consistency and streamline the completion process

Adhere to SOPs

Sample Monitoring Visit SOP

Adhere to SOPs

Sample Monitoring Trip Report Template

Capture a Snapshot in Time

• In ASCEND, Siebel CTMS is configured so that follow-up items, PDs, SAEs and CRF monitoring activities are tracked outside of the trip report

• When a trip report is ready to be completed, the relevant records can be “imported”o Creates a read-only copy that cannot be

modified within the trip report

Track Review Process

• In Siebel CTMS, trip report “Status” field is governed by a state modelo Controls order of status changes and which users can make

which changes• In ASCEND, trip report includes electronic

signature capability with re-authentication and a visible audit trailo Displays complete history of status changes

• In both, the printable trip report does not display reviewer comments, but electronic version does store them, unless deleted

Record Compliant Approvals

• Ink signatures• Re-authentication for status changes• Visible audit trail of status changes

More Conservative Less Conservative

Visible audit trailRe‐authentication

21 CFR Part 11 Interpretation

Ink

Siebel Clinical ASCEND

www.facebook.com/perficientwww.perficient.com

www.twitter.com/perficient_LS

Thank You!For more information, please contact:

Param.Singh@perficient.comLifeSciencesInfo@perficient.com (Sales)

+1 303 570 8464 (U.S. Sales)+44 (0) 1865 910200 (U.K. Sales)