FOR IMMEDIATE RELEASE
Medidata Solutions To Drive Dialogue At Global Industry Events In February
Company to Present at DIA’s 11th Annual Workshop in Japan, Smart Lab Exchange 2008, IIR’s
Clinical Trial Congress and 6th Annual Phase IV Clinical Trials Conference
NEW YORK, NY – January 24, 2008 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced that top executives will present at the following industry events:
DIA’s 11th Annual Workshop in Japan for Clinical Data Management
January 31-February 1, 2008, Tokyo, Japan
Speaker: Barton Cobert, M.D., Vice President, Global Regulatory Initiatives & Pharmacovigilance
Session Title: “The Importance of Reporting Adverse Effects”
Date & Time: February 1, 2008 at 9:30 a.m.
This annual meeting will deliver information to attendees about the clinical data management processes, as well as provide opportunities for clinical data management leaders to discuss the evolution of the industry. In his presentation, Cobert will review the regulatory requirements for safety data reporting in the major regions. Additionally, Cobert’s presentation will address the areas critical to the success of clinical trials, including the requirements and mechanics of safety data collection. He will detail trends in clinical safety data collection, analysis and reporting, life cycle risk assessment, risk management, and risk management plans in the context of clinical trials. Cobert will also discuss clinical transparency in regard to registries of ongoing trials and safety data posted to internet registries, as well as privacy and data transmission issues.
Smart Lab Exchange: Innovative technology and data strategies to drive company knowledge
February 6-7, 2008, London, UK
Speaker: Mukhtar Ahmed, Vice President, Implementation Services
Session Title: “Gaining Competitive Advantage by Minimizing the Pre-Clinical and Development Cycles”
Date & Time: Feb 6, 2008 at 4:00 p.m.
The exclusive Smart Labs 2008 event aims to discuss best practice strategies for accelerating development and quality life cycles. The conference includes a series of interactive workshops around global systems integration, knowledge access and web search, ELNS and LIMS and data innovation. In his presentation Ahmed will address the analytical and decision-making requirements of research scientists and clinicians, explore data accessibility issues using diagnostic data analysis examples, appraise and qualify respective industry growth drivers and propose best practice approaches in application integration and data design that yield cycle time efficiencies.
IIR’s Clinical Trials Congress 2008
February 25-27, 2008, Orlando, Florida
Speaker: Graham Bunn, Vice President of Global CRO Partnerships
Session Title: “EDC-CRO Alliances: Changing Technology, Changing Partnerships”
Date & Time: February 26, 2008 at 2:30 p.m.
The 2008 IIR Clinical Trials Congress will focus on best practices in implementing and executing successful clinical trials. This meeting will address partnerships in drug development, global opportunities for clinical trials, patient recruitment, project management and strategy. Bunn will provide attendees with an overview of the factors driving CROs to implement EDC technology to provide best-of-class solutions for global clinical trials. During his presentation, Bunn will also highlight the growing demands of biopharma companies for CROs to create and monitor studies using leading EDC solutions and detail the new and more flexible partnerships developing between EDC vendors and CROs.
6th Annual Phase IV Clinical Trials Conference
February 28-29, 2008, Miami, Florida
Speaker: Hugh Levaux, Ph.D., Vice President, Product Strategy
Session Title: “Increasing return of investment in sponsoring Phase IV Clinical Trials”
Date & Time: February 29, 2008 at 11:45 a.m.
Currently, Phase IV is the fastest-growing area of clinical research. As the regulatory environment changes, the Phase IV process is becoming an issue for the drug development industry. The 6th Annual Phase IV Clinical Trials Conference will focus on these challenges and offer insight on Phase IV clinical safety, efficiency and cost-effectiveness. Levaux’s session will review the increase in investment of sponsoring Phase IV clinical trials. In addition, his presentation will address issues around analyzing and comparing methods to increase ROI in post-approval studies, assessing current techniques in ROI and employing better methods, examining the use of technology and employing better methods and optimizing EDC and data integration.
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 McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com