Medidata Solutions to Drive Discussion at 42nd Annual DIA Meeting; Key Executives to Present and Chair Conference Sessions on Clinical Data Management and Regulatory Issues.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced that three key executives will be presenting at the 42nd Annual DIA Meeting on June 18-22, 2006 at the Pennsylvania Convention Center The Pennsylvania Convention Center is a multi-use public facility in Philadelphia, Pennsylvania which is designed to accommodate conventions, exhibitions, conferences and other events. in Philadelphia. In addition, Medidata will demonstrate its Rave electronic data capture and reporting solution at booth #229 as well as at the Microsoft booth # 401. At this year's show, Medidata's Vice President of Development Keith Howells, Chief Technology Officer Glen de Vries de Vries. For some persons thus named use Vries. , and Vice President of Global Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas:
-- "Can an EDC System Be Your Integration Hub?"
Speaker: Keith Howells, Vice President of Development
Session 116: Information Technology, Monday, June 19, 2006 at
10:30 a.m.
Howells will illustrate the major application areas and
typical approach of feeding data into a central "hub," while
proposing that the hub of choice should be an electronic data
capture system rather than a traditional clinical data
management system.
-- "Increasing Productivity with Self-documenting Systems"
Speaker: Glen de Vries, Chief Technology Officer
Session 259: Validation, Tuesday, June 20, 2006 at 10:30 a.m.
De Vries will outline study deployment techniques for EDC and
CDMS through the use of self-documenting systems versus
traditional waterfall software development lifecycle
processes. Attendees will learn how self documenting systems
provide requirements in real time and create cost and time
saving efficiencies, as well as lowering risk and increasing
quality.
-- A Regulatory Perspective on Computer Application and Data
Integration in GCP and GLP Studies"
Session Chairperson and Speaker: Earl Hulihan, Vice President
of Global Regulatory Affairs and Quality Assurance
Session 290: Validation, Tuesday, June 20, 2006 at 1:30 p.m.
Hulihan will describe the real-life application of core
validation basics to achieve results consistent with good
industry validation practices for data reliability and
integrity.
As a key member of the planning committee planning committee n (in local government) → comité m de planificación for the DIA Annual Meeting, Hulihan will also chair the Good Clinical Practices Session 213 on Tuesday, June 20, 2006 at 8:30 a.m. This session will highlight current issues surrounding sur·round tr.v. sur·round·ed, sur·round·ing, sur·rounds 1. To extend on all sides of simultaneously; encircle. 2. To enclose or confine on all sides so as to bar escape or outside communication. n. source documentation and data integrity for paper and electronic-based systems with a panel focus on medical charting in today's regulatory environment. As Vice President of Development, Howells is responsible for both the core Rave product as well as for customer-specific integrations and utilities. Howells has over 15 years of experience in the clinical trials business. In his prior position at Oracle, he helped to establish Oracle Clinical as the dominant back-end data management system, initially as head of the pharmaceutical consulting practice and then as vice president of the pharmaceutical applications development group. In this role, he led the development of products for clinical data management, clinical trials management, electronic data capture, medical dictionary A medical dictionary is a lexicon for words used in medicine. The three major English language medical dictionaries are Stedman's, Taber's, and Dorland's medical dictionaries. management, pharmacovigilance pharmacovigilance, n the monitoring of adverse effects of drugs and herbal remedies as they are used in the population. Also called postmarketing surveillance. and clinical data warehousing See data warehouse. data warehousing - data warehouse . De Vries has filled the role of chief technology officer 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 by The New York Times and drew the attention of the Office of Health and Human Services Noun 1. Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Department of Health and Human Services, HHS . He has over 10 years of experience in medical software development, including electronic health records and consumer-targeted products. As president of OceanTek, a web development firm focused on applications for the healthcare industry, he was the chief consultant for a Fortune 500 global e-commerce project, and was the author of web security components currently in use by thousands of web sites and corporate intranets. 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. Hulihan has held a variety of senior management positions in the global pharmaceutical environment serving both pharmaceutical companies and CROs. Prior to joining Medidata Solutions, Hulihan served as the senior vice president of regulatory consulting services Noun 1. consulting service - service provided by a professional advisor (e.g., a lawyer or doctor or CPA etc.) service - work done by one person or group that benefits another; "budget separately for goods and 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 regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. personnel within the U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and European community European Community: see European Union. European Community (EC) Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. and has more than 15 years of experience in clinical medicine as a research specialist, teaching specialist, clinical physiologist physiologist /phys·i·ol·o·gist/ (fiz?e-ol´ah-jist) a specialist in physiology. physiologist a specialist in physiology. and investigator. Hulihan serves on the DIA Advisory Council for North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. . 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 life·blood n. 1. Blood regarded as essential for life. 2. An indispensable or vital part: Capable workers are the lifeblood of the business. of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process the process of bringing life-enhancing 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. |
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