FOR IMMEDIATE RELEASE
Medidata Solutions Shapes Conference Agenda at
43rd Annual DIA Meeting
Key Executives to Present and Chair Conference Sessions on
Adaptive Clinical Trials and Regulatory Issues
NEW YORK, NY – June 11, 2007 – 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®, 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 about Medidata executives, please visit
http://www.mdsol.com/about/team_management.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 volunteerbased 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.
Contact:
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com