FOR IMMEDIATE RELEASE
VP of Global Regulatory Affairs and Quality Assurance Earl Hulihan
to Present at Two Industry Conferences in December
NEW YORK, NY – November 20, 2006 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced that the company’s Vice President of Global Regulatory Affairs and Quality Assurance, Earl Hulihan, will be presenting at two drug development conferences this December. Medidata will continue to lead the conversation on critical topics in the clinical space through Hulihan’s involvement at the following key industry events:
2nd Modern Drug Discovery & Development Summit
December 4–6, 2006, Philadelphia, Pa.
Session title: “Meeting the Expectations of Regulatory Inspectors on Surveillance
Inspections—Putting your Best Foot Forward”
December 5, 9:00 a.m.
In this presentation, Hulihan will discuss companies’ tendency to focus their attention on surveillance inspections from the standpoint of making the visit “painless,” “meeting the opposition,” or just simply “let’s get this over with.” Hulihan will break down the essential components of the surveillance inspection, with specific activities and objectives for prior to, during and after the inspection, ensuring that it is a beneficial operation for all sides. This interactive session will provide detailed examples and allow the attendee to take ownership of methods, responsibilities and outcomes relating to both the audit and to expectations of the company and responsible parties.
DIA’s “The Quest to Enable the Electronic Clinical Trial”
December 5–7, 2006, Baltimore, Md.
Session Title: “Validation Basics”
December 6, 1:30 p.m.
In this tutorial, Hulihan will instruct IT staff, software developers, QA directors, clinical managers and clinical monitors on developing computerized validation systems by providing a detailed understanding of validating computer systems and what they can expect from software vendors and contract research organizations in the future. Attendees will learn why validation is important, what impact it has on their organization and the components of a complete validation project.
About Earl Hulihan
Hulihan brings more than 30 years of experience in quality assurance, regulatory compliance, drug development and clinical research to his role as vice president of global regulatory affairs and quality assurance at Medidata Solutions. Prior to joining Medidata Solutions, Hulihan served as the senior vice president of regulatory consulting services at META Solutions Inc. and vice president of quality systems at EduQuest. In both roles, Hulihan provided regulatory consulting, auditing and training services to the global pharmaceutical, biologics and medical device industries. He has also provided advice and training to regulatory agency personnel within the U.S. FDA and European community and has more than 15 years of experience in clinical medicine as a research specialist, teaching specialist, clinical physiologist, and investigator. Hulihan serves on the DIA Advisory Council for North America and as chair of the DIA Validation Global community.
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 lifeenhancing treatments to market—on five continents and in more than 70 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