FOR IMMEDIATE RELEASE
Company Executives to Address Adaptive Trials, Clinical Data Management,
Informatics and Safety at Global Conferences
NEW YORK, NY – October 10, 2007 – Executives at Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, will present at five leading industry conferences this month:
SMI Clinical Informatics: Data Management, EDC and Standards Conference
October 10–11, 2007, London, UK
Speaker: Graham Bunn, Vice President, Global CRO Partnerships
Session Title: “eClinical Informatics and EDC Systems: A Case Study Approach to eClinical Information Systems”
Date & Time: October 10, 2007 at 2:30 p.m.
Adapting new electronic systems and software applications is the key to successful data management. SMI’s Clinical Informatics conference will cover significant topics and developments surrounding clinical data management, EDC and other e-clinical technologies. Bunn’s presentation will review adaptive clinical trials, integrated voice response systems, electronic patient reported outcomes and the future of eClinical informatics and RDC systems within clinical trials.
DIA Clinical Forum 2007:
17th Annual European Clinical Data Management Conference
October 15–17, 2007, Madrid, Spain
Speaker: Hugh Levaux, Vice President, Product Strategy
Session Title: “The ‘Holy Grail’—Study Design and Study Build as a Seamless Process”
Date & Time: October 16, 2007 at 4:00 p.m.
This 3-day, multi-track European conference will highlight issues surrounding professionals and companies who employ clinical data management, placing a special emphasis on the importance of the clinical team.
Levaux and Charles Beitz, Vice President of TrialSpace Designer Solutions at FastTrack, will demonstrate in real-time how a fully integrated electronic trial environment can be created as a result of the establishment and adoption of robust standards. Attendees will see how an electronic protocol is created (complete with statistical components) and exported to clinicaltrials.gov as well as an unrelated EDC system for database and eCRF set-up.
Speaker: David Quarm, Senior Business Consultant
Session Title: “eIntegrations”
Date & Time: October 16, 2007 at 9:00 a.m.
As organizations implement electronic data collection (EDC) technologies, new perspectives on how to manage data emerge. Quarm will explore e-integrations in clinical trials and the integration of existing patient information into an electronic record of the trial. Furthermore, Quarm will host a panel, featuring Dave Iberson-Hurst, CDISC Representative, Assero Ltd., who will discuss integration with EHRs, Susanne Thomsen of H. Lundbeck, who will detail how to maintain standards on site, and Philip Puls, of NNIT Denmark, who will discuss data and application integration.
IIR’s Clinical Technology Congress
October 22–24, 2007, Philadelphia, Pennsylvania
Speakers: Glen de Vries, Co-founder and Chief Technology Officer
Session Title: “Integrating eClinical Operations: Role and Benefits of Technology”
Date & Time: October 23, 2007 at 2:15 p.m.
Leading electronic data capture (EDC) software has evolved to provide a fully integrated EDC and clinical data management platform. Beyond this platform lies the objective of providing an integrated eClinical backbone that can serve as the sole repository of all transactional data generated in the conduct of clinical trials—clinical, metadata, and operational data. To meet this objective, leading EDC software offers an end-to-end platform, which, when paired with the proper ancillary software, can address the common problems encountered in clinical trial design, operations and analysis.
This session will provide an overview of the ideal architecture for such eClinical platform, as well as provide an overview of the ecosystem of software solutions that help accelerate clinical operations, as well as the flow of data from collection to analysis. Additionally, de Vries will discuss some of the specific tools required to integrate these various technologies and describe and how they can contribute to increasing productivity and time-to-value.
DIA 5th Annual Canadian Meeting
October 28–30, 2007, Ottawa, Canada
Speaker: Barton Cobert, Vice President, Global Regulatory Initiatives & Pharmacovigilance
Session Title: “Where is Drug Safety Going?”
Date & Time: October 29, 2007 at 1:30 p.m.
The 5th Annual Canadian Meeting will cover a number of important issues facing Health Canada, the pharmaceutical industry, health academia and the health care system. In Cobert’s panel session, he will critically examine the current state of the drug safety universe in the U.S. and abroad as well as the changes that have already been implemented and those to come. Additionally, this panel will discuss the political, technical and economic factors in drug safety, as well as how trials are assessed and how to consider the public health outcomes of trials.
Applied Clinical Trials European Summit
October 29–31, 2007, Berlin, Germany
Speaker: Graham Bunn, Vice President, Global CRO Partnerships
Session Title: “Update on EDC in Asia Pacific”
Date & Time: October 29, 2007 at 3:50 p.m.
The Applied Clinical Trials European Summit seeks to discuss the latest developments on vital topics including regulatory issues, trial design, subject recruitment, risk management and other issues pertaining to clinical trials. Bunn will detail the latest developments for EDC trials in Japan and the future for EDC in India, while providing an overview of EDC in Asia as a whole and as compared to the rest of the world.
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