Medidata Solutions to Deliver Valuable Insights at Leading Global Conferences in April
FOR IMMEDIATE RELEASE
Medidata Solutions to Deliver Valuable Insights at
Leading Global Conferences in April
Company Executives to Share Case Studies, Best Practices and Latest Trends at EDC and
Beyond, CDISC European Interchange and Annual SQA Meeting
NEW YORK, NY – April 10, 2007 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced that company executives will speak at the following industry conferences in April:
EDC and Beyond
April 10–12, 2007, Orlando, Florida
Speaker: Hugh Levaux, Ph.D.,Vice President of Product Strategy
Session Title: “Case Study: Integrating an EDC System into a Large Company”
April 12, 2007 at 4:00 p.m.
This year’s EDC and Beyond conference focuses on proven strategies for bringing increased efficiency and speed to the clinical trial process, and features presentations, case studies and interactive panels with pharmaceutical, biotechnology, CRO and EDC experts. In his presentation, Levaux will provide an in-depth look at the development and integration of an EDC system into a large scale pharmaceutical company conducting multicenter clinical trials.
2007 CDISC European Interchange
April 23–26, 2007, Montreux, Switzerland
Speakers: Andrew Newbigging, Senior Director of Research and Development;Michael Posey, Product Manager, invivodata, Inc.
Session Title: “eDiary and EDC System Integration: The Importance of Using CDISC ODM Standards”
April 26, 2007 at 9:00–10:30 a.m.
Workshop Presenters: Andrew Newbigging, Senior Director of Research and Development; Michael Posey, Product Manager, invivodata, Inc.
Workshop title: “Workshop 2: CDISC End to End”
April 23, 2007 at 1:30 p.m.
While focusing on valuable insights, practical experiences implementing CDISC standards, and real-life case studies, the CDISC European Interchange seeks to move the clinical research and development fields forward through a thorough examination of its standards. While the integration of e-clinical data collection systems has long been a topic of discussion, the industry has not been as quick to adopt such integration despite its ability to offer increased efficiency and trial speed. Newbigging and Posey will discuss specific experiences comparing and contrasting ePRO and eCRF integration and working both with and without CDISC standards, including the speed and efficiency benefits of working with CDISC ODM standards.
Newbigging and Posey will also participate in “Workshop 2: CDISC End to End,” along with Medidata partner Fast Track Systems, Inc. The workshop will showcase how eclinical systems can use CDISC standards to streamline trials by quickly sharing data from trial design through capture, submission and archiving.
23rd Annual SQA Meeting
April 29–May 3, 2007, Austin, Texas
Speaker: Earl Hulihan, Vice President of Global Regulatory Affairs and Quality Assurance
Session Title: “Practical Computer System Validation for Management”
May 1, 2007 at 11:00–11:30 a.m.
Speaker: Earl Hulihan, Vice President of Global Regulatory Affairs and Quality Assurance
Session Title: “Clinical Research and Medical Records in Today's Regulatory Environment”
May 1, 2007 at 4:30–5:00 p.m.
Poster Presenter: Earl Hulihan, Vice President of Global Regulatory Affairs and Quality Assurance
Poster Presentation: “Effective Outsourcing: Lessons for Successful Partner Selection and Management”
May 1, 2007 at 5:00–5:30 p.m.
This year’s Annual SQA Meeting will provide guiding principles to the QA professional in addressing a common organizational pain point. Companies often struggle in managing the range of resources required for computer system validation and understanding “How much is enough?” and “How do I determine the correct risk of my company?”
In his two speaking sessions, Hulihan will answer these questions, explore information and security management’s impact in regulated environments, review the current regulatory and intellectual property (IP) protection issues within IT solutions and service providers and discuss the proper plans for selecting, retaining and managing qualified IT professionals. Attendees will come away with an understanding of the key requirements for computer system validation and the resources needed to meet regulatory and industry best practices for demonstrating data integrity.
For background information about Medidata executives, please visit
http://www.mdsol.com/about/team_management.htm.
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