FOR IMMEDIATE RELEASE
Trial Planning Metrics, Inspections of Electronic Clinical Systems, Clinical Trial Safety and
CDISC Implementation Top the Agenda at DIA Clinical Forum and
Other Industry Meetings in Europe, China and India
NEW YORK, N.Y. – October 7, 2010 – 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 October:
DIA 4th Annual Clinical Forum
October 11–13, Lisbon, Portugal
Presentation: “From Protocol Design to Final Reporting: CDISC Implementation”
Speaker: Richard Young, Director, Regional Sales, EMEA
Date & Time: Monday, October 11, 2:00 p.m. WEST
Presentation: “Practical Experiences Transferring Data from EDC to Data Warehouses”
Speaker: Andrew Newbigging, Vice President, Integrations Development
Date & Time: Monday, October 11, 4:00 p.m. WEST
Presentation: “Navigating the Chasm Between EDC and Safety Systems”
Speaker: Sonia Araujo, Manager, Product Management
Date & Time: Tuesday, October 12, 9:00 a.m. WEST
Presentation: “Regulatory Inspection Readiness”
Speaker: Fran Nolan, Vice President, Quality Assurance
Date & Time: Tuesday, October 12, 4:00 p.m. WEST
Presentation: “Inspection of Electronic Clinical Trial Systems: A Supplier Viewpoint”
Speaker: Patricia Beers Block, Vice President, Regulatory Policy
Date & Time: Wednesday, October 13, 9:00 a.m. WEST
Presentation: “Utilizing Metrics to Optimize Clinical Trial Planning and Management”
Speaker: Rick Piazza, Vice President, Product Strategy
Date & Time: Wednesday, October 13, 11:00 a.m. WEST
Presentation: “The Impact of Electronic Health Records (EHRs) on Source Data Validation”
Speaker: Fran Nolan, Vice President, Quality Assurance
Date & Time: Wednesday, October 13, 11:00 a.m. WEST
The DIA 4th Annual Clinical Forum provides attendees with the opportunity to interact with a global audience of qualified professionals, from entry level to expert, in the biopharmaceutical industry, contract service organizations, regulatory agencies, health ministries and universities as well as patients and students. The 2010 theme of “Navigating the Future” will encourage discussion on what the future will bring to clinical trials. To learn more, please visit: DIA Clinical Forum 2010.
PhUSE Annual Conference 2010
October 17–20, Berlin, Germany
Presentation: “Using Web Service Technologies for Incremental, Real-time Data Transfers from EDC to SAS”
Speaker: Andrew Newbigging, Vice President, Integrations Development
Date & Time: Tuesday, October 19, 4:00 p.m. CEST
With the explosive growth of standards, the drive to increase efficiency and reduce costs, and the development of new and complex study designs, companies and organizations are seeking solutions from innovations linked to development of the latest technologies. This year’s conference will focus on the theme of “Innovation Driven by Technology” and will provide attendees with a broad view of what is happening in the industry and guide their search for innovative alternatives. To learn more, please visit: PhUSE Annual Conference.
DIA 5th Annual Conference on Drug Discovery and Clinical Development
October 23–26, Bangalore, India
Presentation: “The Growing Role of Data and Data Management in the Evolution of the Clinical Trial Process”
Speaker: Graham Bunn, Vice President, Partnerships and Alliances
Date & Time: Sunday, October 24, 1:30 p.m. IST
This annual conference hosted by DIA will discuss “Meeting the Challenges of Next Generation R&D: Enhancing Efficiency, Effectiveness and Innovation.” Topics to be explored include drug discovery, regulatory affairs, quality assurance and compliance, pharmacovigilance and drug safety, and clinical data management. To learn more, please visit: Annual Conference on Drug Discovery and Clinical Development.
MAGI’s Clinical Research Conference—2010 West
October 24–27, San Francisco, CA
Presentation: “Above the Bottom Line: How Fees Vary by Site”
Speaker: Lori Shields, Vice President, Data Operations
Date & Time: Monday, October 25, 1:30 p.m. PDT
Model Agreements & Guidelines International (MAGI) is standardizing best practices for clinical research operations, business and regulatory compliance. At this clinical research conference, professionals in the clinical research field will find a coherent and comprehensive program that focuses on current industry needs for applicable information, emphasizing practical tips based on real-life examples. To learn more, please visit: MAGI’s Clinical Research Conference—2010 West.
Shanghai University of Traditional Chinese Medicine and SFDA Joint Workshop
October 29–30, Shanghai, China
Presentation: “Inspection of Electronic Clinical Data Systems—Best Practices”
Speaker: Earl Hulihan, Senior Vice President, Regulatory Compliance
This two-day training will be hosted jointly by the Shanghai University of Traditional Chinese Medicine and China’s State Food and Drug Administration. During the workshop, attendees will discuss industry best practices.
International Symposium in Quantitative Pharmacology (ISQP) in Drug Development
October 29–31, Xiamen, China
Presentation: “A Review of the Current Global Concepts for Data Integrity and Data Quality in Computerized Systems”
Speaker: Earl Hulihan, Senior Vice President, Regulatory Compliance
Date & Time: Sunday, October 31, 10:00 a.m. CST
The 2nd annual ISQP symposium will discuss the latest methodologies in pharmacometrics areas focusing on pharmacokinetics and pharmacodynmics (PK/PD) modeling and simulation in drug development, regulation and clinical applications. Scientific leaders in academia, regulation and pharma will discuss the opportunities and challenges in global drug development and approval. To learn more, please visit: 2nd Annual ISQP.
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:
Susan McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com