Utilizing a Unified Platform to Bridge Geographical

and Departmental Gaps While Expediting an Entire

Development ProgramPresented to DIA-Japan: 31 January 2014

William Gluck, Ph.D.

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Disclaimer

► The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.

► These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners.

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Agenda

1. The Drug Development Process

2. The Drug Development Paradox

3. Regulations and Guidelines

4. Standards – CDISC

5. Leveraging Technology

6. Resource Management

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Overview – The Drug Development Process

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The Clinical Trial ParadoxLeverage technology and process to conduct trials faster and obtain quicker approvals

With speed and more interaction comes a greater risk of error

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Downstream Data Quality at RiskOver time, seemingly insignificant errors accumulate, significantly increasing risk

Combined Human Interaction and Speed in the Clinical Trial Process…

Potential for Error = Increased Risk

Discovery

10 years 3.5 years 6.5 years

Clinical

Pre-Clinical

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How can we reduce the time needed to conduct studies

and also reduce risk? Regulations &

Guidelines Standards - CDISC Leveraging

Technology Resource

Management

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Regulations and Guidelines Help to Accelerate Drug

Development and Reduce Risk

Standardized Data and Process

GCP

ICHFDA

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Standards

CDISC

CDASH ODM STDM AdAM SHAR

E

Leveraging Technology

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The Integrated Approach

Data must be moved in order to create the central database – increases risk of errors

Central Databa

se

EDC

Randomization

Coding

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The Unified

Approach

Reduces risk

Central Databas

e

EDC

Coding

Randomization

Resource Management

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Key Roles and Responsibilities

• Overall support and guidanceClinical R&D Leadership

• Develop Study-specific/Development PlanClinical Study

Team

• Centrally monitor quality across all sites – identify emerging issues

• Coordinate/track and follow-up

CRA/Site Quality

Manager• Data Management Plan – Targeted & Aligned• EDC configuration as a key enabler• Global Data and System Management

Data Management

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Inter-Relationships

Using the Unified Platform – Everything in one place

• CDM• CRA

• Clinical Study Team

• Clinical R&D

Regulations

Standards

Technology

Resources

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Utilizing All Resources

Central Data Repository

Resources

Technology

Standards

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Real Life Example: Value of the Central Repository and Unified Platform

► Drug A: Generation of the ISS and ISE• Different vendors, databases, standards• Time duration: 10 months to generate

► Drug B: Generation of the ISS and ISE• Different CRO vendors for Phase I• Single vendor, single platform database for

Phase II and Phase III studies• Standards enforced (but not CDISC)• Time duration: 4 months to generate

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Summary

How can we reduce the time needed to conduct studies and also reduce risk?

• Leverage Regulations and Standards• Leverage Technology – Reduce

Movement by using a Unified Platform• Leverage Resources – Adjust Roles to

Maximize Effectiveness

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William Gluck, Ph.D.

VP, DATATRAK Clinical Knowledge

DATATRAK

Phone: 440-443-0082 x114

E-Mail: Bill.Gluck@datatrak.com

from Concept to Cure

with DATATRAK ONE

DATATRAK InternationalCleveland, Ohio Bryan, Texas Cary, North Carolina

888.677.DATA (3282) Toll Freewww.datatrak.net

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