Clinical Trial Technology Experts Drive Discussion on Regulatory Challenges, Oncology Trials, Cloud Computing and CRO Partnerships
NEW YORK--(BUSINESS WIRE)-- Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that members of its management team will deliver the following presentations at key events in November:
CDISC Interchange North America
November 1-5, Baltimore, MD
Presentation: “Standards from the Start: CDASH & Protocol”
Chair: David Gemzik, Vice President, Implementation Services
Date & Time: Wednesday, November 3, 2:30 p.m. EDT
Presentation: “Using a Protocol Model to Construct Study Documents”
Speaker: Peter Abramowitsch, Vice President, Trial Planning Development
Date & Time: Wednesday, November 3, 2:30 p.m. EDT
CDISC Interchange North America comes after a recent board meeting in which a new CDISC vision was created and endorsed through the work of the CDISC Board Strategy Committee. The Board and Operations have also been exploring new revenue streams to ensure sustainability of CDISC in the future. The year 2011 will be an important year for CDISC, with several new FDA projects, participation in the SHARP grant with Mayo Clinic and Intermountain Healthcare and the launch of SHARE with the National Cancer Institute. For more information on the event, visit: CDISC Interchange North America.
7th Latin American Congress of Clinical Research
November 10-12, Sao Paulo, Brazil
Presentation: “An Overview of Best Practices from PEACH”
Speaker: Earl Hulihan, Senior Vice President, Regulatory Affairs
Date & Time: Friday, November 12, 1:00 p.m. BRST
Presentation: “The Use of Cloud Computing in Medicine and Research: A Blessing or a Curse – A Practical Discussion”
Speaker: Glenn Watt, Vice President, Information Security and Privacy
Date & Time: Friday, November 12, 1:00 p.m. BRST
The 7th Latin American Congress of Clinical Research will include two pre-congress courses and a two-day conference focusing on both the global and regional aspects of clinical research. Featured topics at the conference include ICH and FDA updates, Latin American regulatory guidelines and ethical issues, infrastructure and components of clinical research, perspectives on the development and comparison of emerging markets of clinical research with Latin America, perspectives on professional development in clinical research, and examples of translational research. Attendees will learn about regulatory principles and procedures of clinical research as well as explore professional clinical research opportunities. To learn more, please visit: 7th Latin American Congress of Clinical Research: Harmonization and the Future of Drug Development in Latin America.
Partnerships in Clinical Trials
November 17-18, Vienna, Austria
Presentation: “EDC Vendor CRO Certification for Increased Sponsors Outsourcing Confidence”
Speaker: Graham Bunn, Vice President, Partnerships and Alliances
Date & Time: Wednesday, November 17, 5:45 p.m. CET
Partnerships in Clinical Trials is one of Europe’s leading industry events for clinical development outsourcing professionals. Clinical development relies heavily on strong, strategic partners now more than ever, due to low R&D productivity, rising costs and the looming patent cliff for blockbuster drugs. As a result, the conference is designed for clinicians to network with different outsourcing contacts in order to build successful, strategic clinical partnerships. To learn more, please visit: Partnerships in Clinical Trials.
Clinical Trials in Oncology
November 30-December 1, Munich Germany
Presentation: “Demonstrating Methods of Overcoming the Challenges of Data Collection and Data Management in Late Phase Oncology”
Speaker: Richard Young, Director, Regional Sales, EMEA
Date & Time: Tuesday, November 30, 4:30 p.m. CET
Clinical Trials in Oncology provides innovative approaches to overcoming the practical challenges of clinical trials in oncology, cutting-edge technologies and strategies to optimize the development of targeted, next generation cancer therapies. Through case study driven presentations from leading pharmaceutical and biotech companies, panel discussions and interactive roundtable discussions, this event will provide strategic, scientific and operational solutions to face the current and upcoming challenges in the field. Attendees will learn how to exploit new opportunities in targeted therapies while mitigating risks and learn directly from the leaders and implementers of cutting edge biomarker and adaptive products. To learn more, please visit: Clinical Trials in Oncology.
Late Phase Drug Development World 2010
December 1-3, London, United Kingdom
Presentation: “Practical Approaches to Using EDC in Late Phase Studies”
Speaker: Patrick Chassaigne, Director, Late Phase Solutions
Date & Time: Wednesday, December 1, 2:20 p.m. GMT
Late phase drug development is growing at around 20 percent annually, exceeding the growth rate of Phase II and III trials. More than $12 billion is currently being spent on Phase IIIb/IV studies as public concerns on the safety of approved drugs prevail together with the need to evaluate the safety and effectiveness of marketed drugs. It is as important as ever to detect, quantify and communicate patient risk with speed and efficiency. The 2nd annual Late Phase Drug Development World Europe 2010 is a strategic forum that addresses major challenges in conducting strategic and compliant late stage studies. To learn more, please visit: Late Phase Drug Development World 2010.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers’ clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata’s advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidata™), randomization and trial supply management (Medidata Balance™), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.
CONTACT:
Lois Paul & Partners
Susan McCarron, 781-782-5767
[email protected]
KEYWORDS: United States Europe North America Canada New York
INDUSTRY KEYWORDS: Technology Data Management Hardware Software Health Biotechnology Clinical Trials Medical Devices Pharmaceutical
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