Clinical Data Management, CROs and Late Phase Top Agenda for Medidata Executives at September Industry Events



    Company Executives to Lead Panels and Deliver Joint Presentations with
Key Pharmaceutical Influencers

    NEW YORK, September 17 /CNW/ - 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 September:

    Society for Clinical Data Management 2007 Fall Conference

    September 16-19, 2007, Chicago, Illinois

    Speaker: Earl Hulihan, Vice President of Global Regulatory Affairs and
Quality Assurance

    Session Title: "Best IT Practices When Preparing for an External Audit"

    Date & Time: September 17, 2007 at 3:30 - 5:00 p.m.

    The SCDM Fall Conference will host clinical data management professionals
at all levels and will feature experts in various fields within CDM offering
their best practice suggestions for trial success. In a panel led by Susan
Howard, Assistant Director at GlaxoSmithKline, Hulihan will deliver a
presentation that provides an overview of information technology practices
that pharmaceutical companies and CROs can employ to be prepared for and host
a successful external IT audit. Emphasis will be on a systems approach in
demonstrating compliant behaviors as well as demonstration through
documentation.

    Pharmaceutical Contract Management Group (PCMG) and Association or
Clinical Data Management (ACDM) Meeting

    September 26, 2007, Savill Court, Surrey, UK

    Speaker: Graham Bunn, Vice President of Global CRO Partnerships

    Session Title: "CRO Alliances: A Vendor's Perspective"

    Date & Time: September 26, 2007 at 11:45 a.m. - 12:30 p.m.

    Panel Title: "Questions and Answers on Any Aspects of Outsourcing
Technology or Data Capture"

    Date & Time: September 26, 2007 at 3:30 - 4:15 p.m.

    This meeting is a joint collaboration between the Pharmaceutical Contract
Management Group and the Association of Clinical Data Managers which will
provide insight into the technological and contractual considerations when
outsourcing clinical data management. As a featured presenter and panel lead,
Bunn will discuss CRO partnerships from a vendor perspective. Attendees will
come away with a view on how these partnerships affect the outsourcing of
clinical data managers.

    The Center for Business Intelligence 10th Registries and Post Approval
Studies Congress

    September 26-28, 2007, Parsippany, New Jersey

    Speaker: Brian E. Leiser, MPPM, Vice President, Late Phase Strategy

    Session Title: "Utilizing EDC in Late Phase Research"

    Date & Time: September 28, 2007 at 9:00 - 9:45 a.m.

    The CBI Registries and Post-Approval Studies Congress offers attendees
the chance to hear keynote presentations from governing bodies on current
initiatives as well as case studies on practical applications for the design
and development of post-approval studies. Leiser, along with co-presenter
Mitchell Wierman, Manager of Global Medical Affairs IT at Johnson & Johnson
Pharmaceutical Research & Development, will highlight EDC implementation
challenges and solutions in late phase research. Attendees will learn
specifics on late phase study solutions such as working with CRO and EDC
partners, educating community-based physicians, optimizing processes for EDC
as well as outcomes and evidence-based data collection.

    The Regulatory Compliance Workshop Groups Solving the Problems in
Designing, Implementing and Managing SOPs for Clinical Research

    September 12-13, 2007, London, England

    Speaker: Fran Nolan, Vice President, Global Quality Assurance

    Session Title: "What are the Current Regulatory Requirements for Standard
Operating Procedures, What do the Regulators Expect and What
SOPs/Documentation should your Organization have in Place?"

    Date & Time: September 12, 2007 at 9:00 - 9:45 a.m.

    This 2-day European Conference will highlight the key practical,
logistical and regulatory issues facing pharmaceutical and clinical research
organizations when it comes to designing, implementing and maintaining SOPs
and documentation. This event will also explain possible solutions to the
problems and "how to put things right".

    This presentation reviews many essential SOPs that should exist and will
also include the importance of the SOPs and their content, and a review of the
possible implications resultant of inadequate or non-existent SOPs. In
addition, the presentation includes recommended SOPs pertaining to audits and
inspections.

    Speaker: Fran Nolan, Vice President, Global Quality Assurance

    Session Title: "Auditors Real Observations and How to Prevent Them"

    Date & Time: September 12, 2007 at 11:00 - 11:45 a.m.

    Other than occasional inspections by FDA, European Clinical
Investigators, sponsors and Contract Research Organizations have not been
subject to many regulatory inspections. Following full implementation of the
EU Directive 2001/20/EC, all member states will be required to appoint
regulatory inspectors. The consequence will be a dramatic increase in the
number of regulatory inspections conducted throughout Europe. Some states,
notably the United Kingdom, have already commenced a major program to inspect
sponsors and investigators and the FDA in the U.S. are already inspecting
heavily. It is imperative that all investigators and sponsors ensure clinical
research is conducted to Good Clinical Practice standards; a poor inspection
may lead to non-acceptance of research data. In the presentation, Fran Nolan,
a qualified Auditor, will examine the kinds of observations that are being
found and how to best deal with them, identifying the most common, repeated
observations, analyzing trends of common observations, identifying new
repeated observations and offering advice on how to prevent common GCP
deviations.

    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




For further information:

For further information: Lois Paul & Partners Susan Lombardo,
781-782-5767 Susan_Lombardo@lpp.com

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