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

FOR IMMEDIATE RELEASE
 
Clinical Data Management, CROs and Late Phase Top Agenda forMedidata Executives at September Industry Events
Company Executives to Lead Panels and Deliver Joint Presentations withKey Pharmaceutical Influencers

NEW YORK, NY – September 17, 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 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 orClinical 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 orData 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 andPost 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_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