Medidata Solutions to Shape Industry Dialogue at CDISC Interchange and Clinical Research Workshop
FOR IMMEDIATE RELEASE
Medidata Solutions to Shape Industry Dialogue at
CDISC Interchange and Clinical Research Workshop
Chief Technology Officer Glen de Vries and Vice President of Global Regulatory Affairs and
Quality Assurance Earl Hulihan to Drive EDC Regulatory Discussion at Key Industry Events
NEW YORK, NY – July 11, 2006 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced that two top executives will be presenting at upcoming standards-focused industry events. Medidata recently expanded research and development capabilities through its Integration Center for Excellence, allowing organizations to place all studies across all therapeutic areas, within all geographic regions, in one database. The center provides biopharmaceutical customers with support for critical industry standards like CDISC and E2B, and gives Medidata executives a unique position to share their knowledge and help others prepare for standards compliance and seamless integration.
Chief Technology Officer Glen de Vries will be speaking at the 2nd Japan CDISC Interchange to be held July 11–13 in Tokyo. At the show, de Vries will present on July 13 at 3:30 p.m. on “Multi-language Clinical Trials and CDISC ODM.” By focusing on the importance of handling data from multiple languages simultaneously within a single trial, de Vries will share how companies can prepare for upcoming developments in clinical data. Attendees will learn how to accomplish this by using and extending the functionality available in the CDISC ODM.
Vice President of Global Regulatory Affairs and Quality Assurance Earl Hulihan will deliver a presentation and act as panel moderator for an interactive “mock audit” during the Regulatory Compliance Workshop Group’s (RCWG) 2006 International Clinical Research Workshop, held on July 12–13 in Virginia. In his presentation, “Preparation for Regulatory and Industry Inspections” on July 13 at 1:50 p.m., Hulihan will reveal to clinical research departments the depth and scope of questions posed by auditors in today’s regulatory environment, offering a practical approach to partnering with auditors. During the “Interactive Mock Audit” directly after his presentation, Hulihan will prepare participants to better field questions during an audit through understanding regulatory and industry expectations, while also addressing FDA and ICH guidelines, GCP-centered 21 CFR Part 11, 312 and 812 regulations and EU Directives.
De Vries has filled the role of CTO since Medidata Solutions was founded in 1999. As lead architect for all of Medidata’s product offerings, de Vries authored the first version of Medidata’s Rave e-clinical trial solution, managed project implementations of Rave and grew the company’s research and development team for subsequent commercial releases. De Vries currently has both U.S. and international patents pending. Prior to his work with Medidata Solutions, his pioneering efforts in online physician/patient relationships were featured in The New York Times and drew the attention of the Office of Health and Human Services. He has more than 10 years of experience in medical software development, including electronic health records and consumer-targeted products.
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.
About CDISC
CDISC is an open, multidisciplinary, non-profit organization. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC is made possible through the work of many volunteers and the generous support of its corporate members, which include major global biopharmaceutical and technology providers, contract research organizations, government, academia and others. CDISC standards are referenced as specifications in FDA Guidance for eSubmissions. Additional information on CDISC and the CDISC open standards/models can be found on the CDISC website at www.cdisc.org.
About The Regulatory Compliance Workshop Group The Regulatory Compliance Workshop Group (RCWG) was set up specifically to provide education and training of the highest standard for the pharmaceutical, medical device, biotechnology and related industries. Through effective qualitative and quantitative research they focus on areas of “pain” within the industry. As a result, RCWG can design practical, relevant and up-to-date workshops and training events that focus on "pain free" solutions. RCWG embraces the "workshop" philosophy with events that are a mix of presentations, workshops and interactive discussions. The presentations provide the theory, general principles and specific information on any a particular topic. The workshops reinforce the theory and the interactive discussions enable the attendees to apply the information to their own situation. For more information, please visit www.rcwg.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