Innovative Learning Opportunities: A Collaboration between Industry and Academia

William Gluck, Ph.D.VP, DATATRAK Clinical and Consulting Services

Datatrak International, Inc.

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.

Disclaimer

Confidential – 3

• A Brief History • The Need • The Program • The Collaboration • Examples of How the Collaboration Works• Questions

Agenda

Confidential – 3

• 1992 – Clinical Trials Research planning begins• 1998 – Clinical Trials Research instituted a

Durham Technical Community College (DTCC) degree program

• 2006 – Clinical Data Management certificate program developed and implemented

• 2008 – DATATRAK and DTCC collaboration begins• 2011 – Collaboration formalized• 2012 – Collaboration expanded

History of the Collaboration

Confidential – 3

• The role of the community college• Economics• Re-Engineering a career• Responding to the need

Addressing Needs

Confidential – 3

• The DTCC CTRA program prepares individuals for a variety of entry-level positions► Clinical Research/ Clinical Operations

Pharmaceuticals/Biotechnology/Medical Devices CROs Research Sites

► Clinical Data Management► Regulatory Affairs/Quality Assurance/Auditing► Product Safety/ Pharmacoviligance► Biostatistics/ Medical Writing

CTRA Program Overview

Confidential – 3

• Traditional classroom instruction • Hybrid approach• Online or eLearning today

Program Evolution

Confidential – 3

• Clinical Data Management Focus► Developed with funding from the North Carolina

Biotechnology Educational Grant program Collaborative effort Innovative approach

► Core Certificate Courses Concepts (CTR-215) Data Collection and Management (CTR-225) Data Trends and Reporting (CTR-230)

Certificate Program

Confidential – 3

• Curriculum must address all aspects of the industry ► Focus on fundamentals of CDM► Focus on industry

Medical Devices Biotechnology Pharmaceuticals

Incorporating Medical Devices in the Mainstream Curriculum

Confidential – 3

• Using real world tools and examples► Concepts

Devices as a key RTP industry sector► Data Collection

Collection approaches for all industry sectors► Data Reporting and Trends

Medical Device submissions The evolving device regulatory environment

Evaluations – Preparation for the Real World

Confidential – 3

• Continue the collaboration – it works!► Student evaluations are positive► Placement and workplace demand

• Expand the Collaboration► Expand to other courses in the program► Potential to expand into other programs…

Future Plans

Confidential – 3

from Concept to Cure

with DATATRAK ONE

DATATRAK InternationalCleveland, Ohio Bryan, Texas Cary, North Carolina

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

®

™