The Top 5 CTMS Enhancements You Can Make

The Top 5 CTMS Enhancements You Can Make

Param Singh, Director of Clinical Trial Management Solutions, Life Sciences, Perficient

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ABOUT PERFICIENT

Perficient is a leading information

technology consulting firm serving

clients throughout North America.

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.

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Founded in 1997

Public, NASDAQ: PRFT

2014 revenue $456 million

Major market locations:

Allentown, Atlanta, Ann Arbor, Boston, Charlotte,

Chicago, Cincinnati, Columbus, Dallas, Denver,

Detroit, Fairfax, Houston, Indianapolis, Lafayette,

Milwaukee, Minneapolis, New York City, Northern

California, Oxford (UK), Southern California,

St. Louis, Toronto

Global delivery centers in China and India

>2,600 colleagues

Dedicated solution practices

~90% repeat business rate

Alliance partnerships with major technology vendors

Multiple vendor/industry technology and growth awards

PERFICIENT PROFILE

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Business Process Management

Customer Relationship Management

Enterprise Performance Management

Enterprise Information Solutions

Enterprise Resource Planning

Experience Design

Portal / Collaboration

Content Management

Information Management

Mobile

BU

SIN

ES

S S

OL

UT

ION

S

50

+ P

AR

TN

ER

S

Safety / PV

Clinical Data Management

Electronic Data Capture

Medical Coding

Clinical Data Warehousing

Clinical Data Analytics

Clinical Trial Management

Healthcare Data Warehousing

Healthcare Analytics

CL

INIC

AL / H

EA

LT

HC

AR

E IT

Consulting

Implementation

Integration

Migration

Upgrade

Managed Services

Private Cloud Hosting

Validation

Study Setup

Project Management

Application Development

Software Licensing

Application Support

Staff Augmentation

Training

SE

RV

ICE

S

OUR SOLUTIONS PORTFOLIO

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WELCOME & INTRODUCTION

Param SinghDirector 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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AGENDA

Topic

Welcome and Introduction

Investigational Product Tracking

Electronic Signatures for Trip Reports

Protocol Progress

Protocol Expenses

Site Selection

Q&A

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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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# 1: INVESTIGATIONAL PRODUCT TRACKING

• Manage and schedule shipments from manufacturer to depots or directly to sites

Manufacturer

• Store product until ready to ship to site

Depot• Receive

shipment, record quantities received, used, spoiled, destroyed, etc.

Site

• Send remaining product to sponsor for destruction

Sponsor

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Setup

– Create new screens & views to track

• Manufacturer & depot

• Inventory transactions that occur between the depot and site

• Inventory levels at each depot and site

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How It Works

– Create manufacturer and depot records

• Record outbound transactions under manufacturer or depot as they occur

• Track inventory information for depots and sites, such as dates, number of units

received, and number of units destroyed

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Pros

– Robust inventory tracking at depot and site level

– Increased inventory level visibility at depot and site

– Optimal querying and reporting capability

– Complete traceability

Cons

– More effort involved to implement

– Not ideal for tracking ancillary supplies

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INVESTIGATIONAL PRODUCT TRACKING

DEMO

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#2: ELECTRONIC SIGNATURES FOR TRIP REPORTS

Paper Process Challenges for Trip Reports

• Completion of the trip report is not centralized

• Submission of trip report for review occurs outside of an electronic system

• Versions and iterations of trip reports get lost

• Review of trip reports occur outside of an electronic system

• Final version of trip report is routed manually for signature

• Paper copy is then scanned and archived

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#2: ELECTRONIC SIGNATURES FOR TRIP REPORTS

Approval Options

• 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

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ELECTRONIC SIGNATURES FOR TRIP REPORTS

DEMO

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#3: PROTOCOL PROGRESS

Commonly Requested CTMS Metrics

• Metrics to capture and track clinical information at multiple levels (protocol, region, and

country level)

• Metrics to monitor the project status and benchmark it against performance milestones,

critical events, and budgeted costs

• Subject status and enrollment rates plotted for sites, regions, and protocols

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Additional Metrics Available via Configuration

• Study dashboard / protocol summary

– High-level view of progress of all studies

• Protocol name, status, phase, etc.

– Planned vs. actual

• Subject forecasting: # screened, # enrolled, # completed, etc.

• Site progress: # initiated, # active, # completed, etc.

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• Study dashboard / protocol summary (cont.)

– Key study milestone tracking

• Signed protocol

• 1st SIV

• FSFV

• LSLV

• Database lock

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• Study dashboard / protocol summary (cont.)

– Study turnaround metrics

• Approved protocol to FPI

• Enrollment time period

• LPO to final database lock

• Final database lock to final analysis

• Final analysis to CSR

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PROTOCOL PROGRESS

DEMO

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#4: PROTOCOL EXPENSESVanilla

• No way to tell total spend in conducting a study

• Only investigator payments

Additional Needs for Finance Tracking

• Ability to budget amounts for specific types of expenses

• Ability to track actual as they are incurred

• Ability to track totals across payment types as well as grand totals of all expenses

separate from investigator payments

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PROTOCOL EXPENSES

DEMO

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#5: SITE SELECTION

Basic Attributes

• Account

– Name, Type, Location,

Address

• Contact

– Last Name, First

Name, Type, Specialty,

Address

Additional Searchable Criteria

• Categories

• Assessments

• Previous Protocols

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SITE SELECTION

DEMO

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QUESTIONS?

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For more information, please contact:

[email protected]

[email protected] (Sales)

+1 303 570 8464 (U.S. Sales)

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

THANK YOU

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Technology

The Top 5 CTMS Enhancements You Can Make