Utilizing a Unified Platform to Bridge Geographical
and Departmental Gaps While Expediting an Entire
Development Program
P...
Disclaimer
►

►

The views and opinions expressed in the following
PowerPoint slides are those of the individual presenter...
Agenda
1.

The Drug Development Process

2.

The Drug Development Paradox

3.

Regulations and Guidelines

4.

Standards –...
Overview – The Drug Development
Process

Confidential – 4
The Clinical Trial Paradox
Leverage technology
and process to conduct
trials faster and obtain
quicker approvals

With spe...
Combined Human Interaction
and Speed in the Clinical Trial
Process…
Potential for Error = Increased
Risk
Downstream Data Q...
How can we reduce the time
needed to conduct studies and
also reduce risk?
 Regulations

&

Guidelines
 Standards - CDIS...
Regulations and Guidelines Help to
Accelerate Drug Development and
Reduce Risk
ICH

FDA

GCP

Standardized Data and
Proces...
Standards

CDISC
CDASH

Confidential – 9

ODM

STDM

AdAM

SHARE
Leveraging Technology
The Integrated Approach
EDC

Randomization

Central
Database

Coding

Data must be moved in order to create the
central da...
The Unified
Approach

Central
Database

EDC

Coding

Randomizatio
n

Reduces risk
12
Confidential –
Resource Management
Key Roles and Responsibilities
Clinical R&D
Leadership
Clinical Study
Team
CRA/Site
Quality Manager

Data
Management
14
Co...
Inter-Relationships
• Clinical
R&D

• Clinical
Study
Team
Regulations

Resources

• CRA

Standards

Technology

• CDM

Usi...
Utilizing All Resources

Standards
Technology

Resources

Central Data Repository
16
Confidential –
Real Life Example: Value of the Central
Repository and Unified Platform
►

Drug A: Generation of the ISS and ISE

• Differ...
Summary
How can we reduce the time needed to
conduct studies and also reduce risk?

• Leverage Regulations and Standards
•...
William Gluck, Ph.D.
VP, DATATRAK Clinical Knowledge
DATATRAK
Phone: 440-443-0082 x114
E-Mail: Bill.Gluck@datatrak.com

19...
from Concept to Cure
with D ATATRAK ONE

®

™

DATAT R A K International
Cleveland, Ohio
Bryan, Texas
Cary, North Carolina...
Upcoming SlideShare
Loading in …5
×

Utilizing a Unified Platform to Bridge Geographical and Departmental Gaps While Expediting an Entire Development Program

1,064 views

Published on

Presentation discusses:
The Drug Development Process
The Drug Development Paradox
Regulations and Guidelines
Standards - CDISC
Leveraging Technology
Resource Management

Published in: Technology, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
1,064
On SlideShare
0
From Embeds
0
Number of Embeds
40
Actions
Shares
0
Downloads
8
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Utilizing a Unified Platform to Bridge Geographical and Departmental Gaps While Expediting an Entire Development Program

  1. 1. Utilizing a Unified Platform to Bridge Geographical and Departmental Gaps While Expediting an Entire Development Program Presented to DIA-Japan: 31 January 2014 William Gluck, Ph.D.
  2. 2. 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 Confidential – 2
  3. 3. Agenda 1. The Drug Development Process 2. The Drug Development Paradox 3. Regulations and Guidelines 4. Standards – CDISC 5. Leveraging Technology 6. Resource Management Confidential – 3
  4. 4. Overview – The Drug Development Process Confidential – 4
  5. 5. The Clinical Trial Paradox Leverage technology and process to conduct trials faster and obtain quicker approvals With speed and more interaction comes a greater risk of error Confidential – 5
  6. 6. Combined Human Interaction and Speed in the Clinical Trial Process… Potential for Error = Increased Risk Downstream Data Quality at Risk Over time, seemingly insignificant errors accumulate, significantly Discovery increasing risk 10 years Confidential – 6 Clinical Pre-Clinical 3.5 years 6.5 years
  7. 7. How can we reduce the time needed to conduct studies and also reduce risk?  Regulations & Guidelines  Standards - CDISC  Leveraging Technology  Resource Management Confidential – 7
  8. 8. Regulations and Guidelines Help to Accelerate Drug Development and Reduce Risk ICH FDA GCP Standardized Data and Process Confidential – 8
  9. 9. Standards CDISC CDASH Confidential – 9 ODM STDM AdAM SHARE
  10. 10. Leveraging Technology
  11. 11. The Integrated Approach EDC Randomization Central Database Coding Data must be moved in order to create the central database – increases risk of errors Confidential –11
  12. 12. The Unified Approach Central Database EDC Coding Randomizatio n Reduces risk 12 Confidential –
  13. 13. Resource Management
  14. 14. Key Roles and Responsibilities Clinical R&D Leadership Clinical Study Team CRA/Site Quality Manager Data Management 14 Confidential – • Overall support and guidance • Develop Study-specific/Development Plan • Centrally monitor quality across all sites – identify emerging issues • Coordinate/track and follow-up • Data Management Plan – Targeted & Aligned • EDC configuration as a key enabler • Global Data and System Management
  15. 15. Inter-Relationships • Clinical R&D • Clinical Study Team Regulations Resources • CRA Standards Technology • CDM Using the Unified Platform – Everything in one place 15 Confidential –
  16. 16. Utilizing All Resources Standards Technology Resources Central Data Repository 16 Confidential –
  17. 17. 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 • • • • 17 Confidential – 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
  18. 18. Summary How can we reduce the time needed to conduct studies and also reduce risk? • Leverage Regulations and Standards • Leverage Technology – Reduce Movement by • 18 Confidential – using a Unified Platform Leverage Resources – Adjust Roles to Maximize Effectiveness
  19. 19. William Gluck, Ph.D. VP, DATATRAK Clinical Knowledge DATATRAK Phone: 440-443-0082 x114 E-Mail: Bill.Gluck@datatrak.com 19 Confidential –
  20. 20. from Concept to Cure with D ATATRAK ONE ® ™ DATAT R A K International Cleveland, Ohio Bryan, Texas Cary, North Carolina 888.677.DATA (3282) Toll Free www.datatrak.net

×