Medidata Solutions to Drive Dialogue at Global Industry Events in February
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.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.