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Medidata Solutions Shapes Conference Agenda at 43rd Annual DIA Meeting
Medidata Solutions executives will discuss key issues in
presentations at the 43rd Annual DIA Meeting, to be held on June
17-21, 2007, at the Georgia World Congress center in Atlanta, Ga.
Medidata presentations will focus on today's e-clinical environment,
from auditing and adaptive clinical trials to regulatory issues and
validation. In booth #1327 at this year's meeting, the Company will
showcase Medidata Rave(R), the industry-leading electronic data
capture, management and reporting solution. Joining Medidata will be
key technology partners to demonstrate how Rave, integrated with
partner applications, meets a range of clinical data management needs.
Medidata executives will be available to discuss Rave's role in
dynamically linking clinical and operational data.
Medidata's co-founder and Chief Technology Officer Glen de Vries
and Vice President of Global Regulatory Affairs and Quality Assurance
Earl Hulihan will be participating in the following sessions:
"Assessing and Auditing Clinical Computerized Systems"
Session Chair: Earl Hulihan, VP of Global Regulatory Affairs &
Quality Assurance
Validation Track: Wednesday, June 20, at 8:30 a.m. ET, Room A311
As session chair, Hulihan will lead a discussion on the key
requirements needed for computer system validation to demonstrate data
integrity and meet regulatory and industry best practices. Clinical
research experts from Northeast Clinical Research Center, ICON
Clinical Research and the Lehigh Valley Health Network will join
Hulihan in this session.
"The Role of Electronic Data Capture in Adaptive Clinical Trials"
Session Chair: Glen de Vries, Co-founder & Chief Technology
Officer
eClinical Track: Wednesday, June 20, 10:30 a.m. ET, Room A314
Jerry Schindler, DrPH, Vice President, Late-Stage Clinical
Development Statistics at Merck & Co., and Michael Borkowski, General
Manager of the clinical technologies group at United BioSource
Corporation, will join de Vries to discuss the operational challenges
of adaptive clinical trials by defining the requirements and processes
for successfully implementing adaptive clinical trials through the use
of EDC.
"The Process Taken and Likely Outcome from Red Apple II"
Speaker: Earl Hulihan, VP of Global Regulatory Affairs & Quality
Assurance
Validation Track: Thursday, June 21, 8:30 a.m. ET, Room A313
As co-chair of The Red Apple II team of international participants
from the academic and government industries, Hulihan will discuss how
the team created and implemented the "Computerized Data Systems for
Nonclinical Safety Assessment: Current Concepts and Quality Assurance"
standard in 1987. After it was published by the DIA, it stood as the
de facto standard for over 20 years. Hulihan will also address how the
team updated original material to reflect the current environment and
the new challenges confronting non-clinical laboratories.
"Presenting Your Investigational Site's Use of EDC: Best
Practices"
Speaker: Earl Hulihan, VP of Global Regulatory Affairs & Quality
Assurance
GCP Track: Thursday, June 21, 10:30 a.m. ET, Room B405
During this presentation, Hulihan will draw on his extensive
experience as a clinical investigator to provide practical advice on
how to prepare site staff for the unique challenges posed in hosting
an audit in an EDC environment. Through a discussion of real-life
examples and focused strategies, attendees will learn the tactics
needed to conduct an audit with a successful outcome.
For background information on Medidata executives, please visit
http://www.mdsol.com/about/team.htm.
About the Drug Information Association (DIA)
The Drug Information Association serves more than 25,000
professionals in the biotechnology, pharmaceutical and regulatory
industries worldwide. Through its domestic and international meetings,
training courses, workshops and webinars, DIA provides a neutral
global forum for the exchange of information critical to the
advancement of the drug discovery and lifecycle management processes.
Headquartered in Horsham, Pa., USA, and with offices in Basel,
Switzerland and Tokyo, Japan, the association is led by its
volunteer-based board of directors and executive management team. For
more information, visit www.diahome.org or call 215.442.6100.
About Medidata Solutions Worldwide
Medidata Solutions helps the world's leading pharmaceutical,
biotechnology, medical device and research organizations maximize the
value of their clinical research investments. Innovative process
design, technology and services streamline clinical trials by
providing early visibility to reliable clinical data - the lifeblood
of every research organization. Working with companies and
institutions both large and small, Medidata Solutions helps clinical
researchers safely accelerate the process of bringing life-enhancing
treatments to market - on six continents and in more than 80
countries. Medidata Solutions brings significant value to its broad
client base with deep clinical experience and expertise in more than
20 therapeutic areas, projects in Phase I, II, III, IV, registries and
surveillance, and studies with thousands of investigators and
tens-of-thousands of subjects. For more information, please visit
www.mdsol.com.