Empresas y finanzas
Medidata Solutions to Deliver Valuable Insights at Leading Global Conferences in April
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:
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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 multi-center
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 e-clinical 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.
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For background information about Medidata executives, please visit
http://www.mdsol.com/about/team.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.