Medidata Solutions Adds Earl Hulihan as Vice President of Global Regulatory Affairs and Quality Assurance
FOR IMMEDIATE RELEASE
Medidata Solutions Adds Earl Hulihan as Vice President of
Global Regulatory Affairs and Quality Assurance
New VP to Co-Chair DIA’s 2006 Red Apple 2 Conference and
Lead Creation of Benchmark Manual for Non-Clinical Safety Best Practices
NEW YORK, NY – March 20, 2006 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced the addition of Earl Hulihan as vice president of global regulatory affairs and quality assurance. With more than 30 years of experience in quality assurance, regulatory compliance, drug development and clinical research, Hulihan will be responsible for maintaining the highest standards for all Medidata products and services and ensuring compliance with U.S. and international clinical and quality regulations.
Prior to joining Medidata Solutions, Hulihan held a variety of senior management positions within the global pharmaceutical environment serving both sponsors and contract research organizations (CROs). As senior vice president of regulatory consulting services at META Solutions Inc. and vice president of quality systems at EduQuest, he 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.
“Medidata remains committed to providing software and services that support compliance with user requirements and designated quality standards,” said Tarek Sherif, CEO of Medidata Solutions. “Earl’s experience working with sponsors and CROs in a global environment will be crucial as we continue to expand our services to customers who are facing increasing regulatory and safety pressures.”
As co-chair of the Drug Information Association’s 2006 Red Apple 2 Conference on Computerized Systems for Non-Clinical Safety Assessment, Hulihan will be among a select group of international participants from industry, government and academia to create an up-todate benchmark manual for Non-clinical Safety Best Practices. Experts will collaborate to update existing information, strengthen the original reference document by addressing new areas, and exchange information on global regulatory and industry best practices. The conference will be held March 22–24, 2006 at DIA World Headquarters in Horsham, Pa.
A frequently featured speaker, instructor and program chair at key industry events, Hulihan is also currently the chair of the DIA’s Validation SIAC and serves on the DIA Advisory Council for North America. He also serves on the editorial board of the Guide to Good Clinical Practice and as a contributing author to the textbook New Drug Approval Process with sections on quality assurance and HIPAA. In addition to advanced training in medicine, physiology, psychology and computer science, Hulihan also holds a masters degree in education with bachelor degrees in education and the sciences.
“Medidata Solutions has built a reputation for providing technologies and services that are advancing clinical trials on a global scale,” said Hulihan. “I am excited to join Medidata’s team of innovative employees and look forward to contributing to the company’s future successes.”
About The Red Apple Conference
In 1987, the Office of Regulatory Affairs of the Food and Drug Administration, the National Center for Toxicological Research (NCTR) and the NCTR Associated Universities, Inc. conducted a conference at the Red Apple Conference Center in Heber Springs, Arkansas on quality assurance of computerized systems used in non-clinical safety assessment. The “Red Apple Conference” was a milestone event in establishing best practices in the design and validation of computerized systems in nonclinical laboratories. The outcome of the conference was a reference published by the DIA, “Computerized Data Systems for Non-clinical Safety Assessment: Current Concepts and Quality Assurance”. Although this publication has served the agency and the regulated industry well, non-clinical laboratory science and technology has changed significantly since the conference. The purpose of this conference is to review the original reference and update the material to address the current environment and new challenges confronting non-clinical laboratories. For more information, visit www.diahome.org.
About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology and medical device companies realize the maximum potential value from their clinical research investments. Working with companies large and small, Medidata Solutions helps accelerate the process of bringing life-enhancing treatments to market—on five continents and in more than 70 countries. Innovative process design, technology and services can streamline clinical trials by providing early visibility to clinical data for faster decision-making, optimized resources and lower execution risk. Medidata Solutions’ broad client base and deep clinical experience provide value for the world’s leading pharmaceutical, biotechnology and medical device companies, 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. To learn more about Medidata Solutions, please visit www.mdsol.com.
Contact:
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com