Leveraging Siebel Clinical Trial Management

System for Risk-Based Monitoring

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ABOUT PERFICIENT

Perficient is a leading information technology and

management consulting firm serving clients

throughout North America.

We help clients implement digital experience, business optimization,

and industry solutions that cultivate and captivate customers, drive

efficiency and productivity, integrate business processes, improve

productivity, reduce costs, and create a more agile enterprise.

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PERFICIENT PROFILEFounded in 1997

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Dedicated solution practices

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OUR SOLUTIONS PORTFOLIOBusiness Process

Management

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BU

SIN

ES

S S

OL

UT

ION

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SE

RV

ICE

S

CL

INIC

AL / H

EA

LT

HC

AR

E IT

50

+ P

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TN

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S

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WELCOME/INTRODUCTION

Param Singh

Director of Clinical Trial Management Solutions

Life Sciences, Perficient

CTMS practice lead since 2008

– Leads the team that implements, supports, enhances, and integrates Siebel Clinical

Extensive Siebel Clinical implementation experience

– 15+ years of experience implementing Siebel Clinical

– 30+ implementations and integrations

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

for Siebel Clinical

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CTMS SERVICES

Implementation

Manage implementations of Siebel

CTMS/ASCEND.

Integration

Build interfaces between Siebel CTMS

and other clinical and safety systems.

Training

Develop and/or deliver standard and

custom training classes and materials.

Process Guidance

Provide insight, advice, and solutions

for specific CTMS issues, based on

industry best practices.

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TODAY’S AGENDA

• Define risk-based monitoring (RBM)

• Explore how RBM works

• Examine a sample RBM risk assessment

• Discuss why a clinical trial management system (CTMS) is a logical fit for RBM

• Translate a sample RBM scenario into CTMS

• Summarize the key takeaways from today’s discussion

• Answer questions

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RISK-BASED MONITORING (RBM) DEFINED

What It’s Not

• High-risk monitoring

• 100% remote/virtual monitoring

• Site abandonment

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RBM DEFINED

What It Is

The process of:

1. Defining the data and processes that are deemed critical to patient safety and data

quality

2. Identifying the risks that could degrade either (patient safety and data quality)

3. Establishing processes to minimize those risks

4. Setting risk indicators and thresholds that will trigger an investigation and

corrective action

*Definition excerpted from inVentiv Health Clinical’s June 2014 white paper entitled Managing Clinical Trial Risk: It's a

Tough Job, But One Person Has To Do It

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RBM DEFINED

RBM Characteristics

• Unique monitoring plan per study, based on a risk assessment of that study

• Combination of remote/virtual and on-site monitoring

• Dynamic monitoring schedule; monitoring visits take place after a site breaches a

predetermined threshold for one or more risk indicators

• Dynamic monitoring visit style and content; depends on the severity of the risk

indicator(s) and the frequency of breaches

• Limited source data verification (SDV), performed as needed to support investigations

into triggering issues

o Critical data and minimum SDV percentages may be defined in the monitoring plan

for each study

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RBM DEFINEDWhy It’s Good

• Concentrates monitoring resources on sites that need the most support/oversight

• Reduces travel time and expense for monitors

• Focuses SDV on data most likely to have quality issues

• Recommended by regulatory authorities all over the globe as a logical, practical way to

reduce the time and cost of clinical studies

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Complete Risk Assessment for the

Study

Determine Risk Indicators & Thresholds

Design Monitoring Plan

Track Site Performance Against

Thresholds

When a Threshold is Breached, Monitor the

Site per the Plan

HOW RBM WORKS

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SAMPLE RBM RISK ASSESSMENT

Risk Area/

Category

Potential Risk

Assessed

Risk Examples/Indicators

(Study-Specific)

Severity Tolerance

Threshold

Performance Wrong patient

population

Too many screen failures High 2 per 25

subjects

screened

Performance Unmotivated site Slow subject enrollment Medium 2 per 7

calendar days

Compliance Non-compliant

site

Too many protocol deviations High 1 per 30

subjects

enrolled

Compliance Unresponsive

site

Action items remain open too long Low >30 calendar

days open

Budget Poor subject

experience

Too many early terminations Medium 3 per 25

subjects

enrolled

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WHY CTMS IS LOGICAL FOR RBM

• CTMS already contains study, site, and subject data

• Site protocol deviations are already tracked in CTMS

• Site follow-up items are already tracked in CTMS

• Subject adverse events are already tracked in CTMS

• Subject screen failures are already tracked in CTMS

• Subject early terminations are already tracked in CTMS

• Monitoring reports are already managed in CTMS

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SAMPLE RBM SCENARIO

# Potential Risk Indicator Threshold CTMS Trigger

1 Wrong patient population Too many screen failures 2 per 25

subjects

screened

Site reports a 3rd screen failure for every 25

subjects screened

2 Unmotivated site Slow subject enrollment 2 per 7

calendar days

Site enrolls 2 or fewer subjects for every 7

calendar days, calculated from the site

Activation Date

3 Non-compliant site Too many protocol

deviations

1 per 30

subjects

enrolled

Monitor logs a 2nd protocol deviation against

a site for every 30 subjects enrolled

4 Unresponsive site Action items remain

open too long

>30 calendar

days open

Site action item’s Due Date becomes 31

days overdue and the Completion Date field

is blank

5 Poor subject experience Too many early

terminations

3 per 25

subjects

enrolled

Site reports a 4th early termination for every

25 subjects enrolled

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SETTING THRESHOLDS IN CTMS

Before study start-up, define all risk thresholds in RBM Administration screen

• Potential Risk #1: Define threshold for site screen failures as: Site reports a 3rd screen

failure for every 25 subjects screened

• Potential Risk #2: Define threshold for site subject enrollment as: Site enrolls 2 or

fewer subjects for every 7 calendar days (back end code will know the date to use to

start the 7 days calculation)

• Potential Risk #3: Define threshold for site protocol deviations as: Monitor logs a 2nd

protocol deviation against a site for every 30 subjects enrolled

• Potential Risk #4: Define threshold for site action items as: Site action item’s Due Date

becomes 31 days overdue and the Completion Date field is blank

• Potential Risk #5: Define threshold for site early terminations as: Site reports a 4th

early termination for every 25 subjects enrolled

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SETTING THRESHOLDS IN CTMS

May also want to define SDV% of critical data based on overall site risk

• Sites calculating as LOW risk = 10% SDV

• Sites calculating as MODERATE risk = 50% SDV

• Sites calculating as HIGH risk = 100% SDV

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TRIGGER NOTIFICATION OPTIONS

• Alert appears on Home screen upon logging in

• Email sent to pre-defined email address for each site

• Visual dashboard in CTMS displays sites as green, yellow, or red, depending on the

thresholds they’ve breached

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MONITORING RESPONSES TO NOTIFICATIONS

The study-specific monitoring plan will dictate the type of monitoring action required for the

risk indicators and thresholds determined in the risk assessment

• If excessive early terminations might indicate a poor subject experience at the site, an

on-site visit might be warranted to inspect the facility,

observe the site personnel interactions with the

subjects, and to interview the subjects

• If a site is slow to enroll, a

remote monitoring session

might be sufficient to discuss

the efforts they are making,

what’s working and what’s

not, and to brainstorm solutions

Complete Risk Assessment for the

Study

Determine Risk Indicators & Thresholds

Design Monitoring Plan

Track Site Performance Against

Thresholds

When a Threshold is Breached, Monitor

the Site per the Plan

When a Threshold is Breached, Monitor

the Site per the Plan

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ULTIMATE IT LANDSCAPE FOR RBM

CDA

CTMS

CDMS/EDC

Argus

• Visual dashboard in CDA with alerts

related to both data and processes

• Thresholds and notifications can be set in

one place for data from all systems

• CDA dashboards can be made visible in

CTMS for greater efficiency

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KEY TAKEAWAYS

• RBM is NOT high-risk monitoring, 100% remote/virtual monitoring, or site abandonment

• RBM IS a unique and dynamic monitoring approach, rooted in study-specific risk

assessments, that employs a combination of remote and on-site monitoring based on

predetermined risk indicators and thresholds

• RBM is GOOD because it concentrates monitoring resources on sites and data that

need the most support/oversight, and reduces the overall cost of clinical studies

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KEY TAKEAWAYS

• RBM is a process that takes place for each and every study

1. Complete a risk assessment for the study

2. Determine risk indicators and thresholds

3. Design monitoring plan

4. Track site performance against thresholds

5. When a threshold is breached, monitor the site per the plan

• CTMS is a logical place to manage RBM because:

o It already contains study, site, and subject data

o Monitoring reports are already managed in CTMS

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KEY TAKEAWAYS

• CTMS is used to:

o Define risk indicators and thresholds for each study

o Track site performance against defined thresholds

o Notify monitors when thresholds are breached

• Monitors then investigate issues and perform SDV%, as prescribed in the

monitoring plan

• The ideal IT landscape for RBM includes the integration of safety data (Argus), patient

data (OC), and clinical trial management data (CTMS) into a single analytics tool (CDA)

that serves as a central location for defining risk indicators, setting thresholds, and

overseeing site performance against those thresholds

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QUESTIONS?

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Next up:

February 4, 2016

Minimize the Impact of E2B(R3) on Drug Safety Operations with

Argus Safety

http://www2.perficient.com/webinar/Minimize-the-Impact-of-E2B(R3)-on-

Drug-Safety-Operations-with-Argus-Safety

February 18, 2016

Interactive Business Intelligence for Big Data in Life Sciences

http://www2.perficient.com/webinar/Interactive-Business-Intelligence-for-

Big-Data-in-Life-Sciences

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