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

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