FOR IMMEDIATE RELEASE
Company Executives to Chair Sessions and Present on Clinical Data Integrity, Cost Containment, Trial Design and Contract Management
NEW YORK, N.Y. – September 8, 2008 – Medidata Solutions, a leading provider of clinical trial solutions, today announced that its top executives have been invited to share their expertise and insights at the following industry events:
DIA Computerized Systems in Clinical Research
September 8, 2008, Horsham, PA
Conference Chair: Earl Hulihan, Vice President, Global Regulatory Affairs & Quality Assurance and Corporate Compliance Officer
Chapter Chair: Fran Nolan, Vice President, Global Quality Assurance
Chapter Chair: Glenn Watt, Corporate Security & Privacy Officer, Vice President, Global
Information Security and Privacy
This event, a continuation of the Red Apple II Conference, will bring together 100+ clinical research experts and Regulators in an effort to create an up-to-date benchmark manual for “Computerized Systems in Clinical Research: Current Quality and Data Integrity Concepts.” Chairs Hulihan, Nolan and Watt will advise and lead attendees in developing an industry “Best Practices” reference text and document current technologies, new issues and exchange information on global regulatory and industry best practices.
IDC’s Life Sciences and Technology Insight Forum
September 14-16, 2008, Philadelphia, PA
Session Title: “Operational Excellence in Clinical Research: From Study Design to Data Lock”
Speaker: Glen de Vries, President
Date & Time: September 15, 2008 at 11:00 am
Speaker: Ed Seguine, General Manager, Trial Planning Solutions
Date & Time: September 15, 2008 at 2:00 pm
This invitation-only forum focuses on the business imperatives and benefits associated with the new generation of technologies to support the life sciences industry. Lending their expertise on these topics, de Vries and Seguine will discuss how more mature EDC/CDM offerings, in conjunction with a new generation of study design and financial benchmarking tools, are increasingly eliminating redundant or error-prone steps within and between various stages of the clinical process. They will also demonstrate how adopting a standards-based approach enables operational excellence, as well as maximizes value to sponsors, by supporting a best-in-class solution architecture through full interoperability between systems.
ExL Pharma's Clinical Cost Containment Conference
September 15-16, 2008, Philadelphia, PA
Session Title: “Understanding the Value of Simple Design and the Unnecessary Costs of Added Complexity”
Speaker: Ed Seguine, General Manager, Trial Planning Solutions
Date & Time: September 16, 2008 at 9:05 am
A seemingly complex task, trial design can actually be quite simple – and extremely valuable – with the right solutions and processes in place during the planning stages. In this session, Seguine will provide insight into what is and is not essential to include in trial protocol, how to select the appropriate number of procedures and patients for each study, and how to identify innovative trial designs and their cost impacts. He will also advise attendees on how to meet the minimum requirements for regulatory approval and how to establish appropriate endpoints for trial protocol to keep spending in check.
IIR’s 15th Annual Cost & Contract Management for Clinical Trials Conference
September 22-24, 2008, Philadelphia, PA
Session Title: “Improve your Planning Processes by Developing a Concise Protocol for New Contracts”
Speaker: Ed Seguine, General Manager, Trial Planning Solutions
Date & Time: September 23, 2008 at 9:30 am
Clinical trial agreement negotiation has become one of the most common causes of delay in trial studies. Straight-forward contract and process improvements, such as those that will be showcased at this annual conference, can help both parties involved to accomplish their objectives by saving time, reducing risks and cutting costs. In this session, Seguine will explain how eProtocols can reduce trial costs, increase time to data lock and result in fewer trial glitches.
CBI’s 11th Registries and Post Approval Congress
September 23-25, 2008, Washington, D.C.
Session Title: “Challenges and Best Practices using Electronic Data Capture (EDC) Systems for Peri- and Post Approval Studies”
Speaker: Patrick Chassaigne, Director, Late Phase Solutions
Panel Participant: Dave Provost, Vice President, Late Phase Services, INC Research
Date & Time: September 25, 2008 at 11:35 am
With post-trial surveillance studies increasingly routine, bio/pharma and medical device companies are now applying the tools and processes used for pre-approval clinical studies
for their late stage studies. This presentation will help delegates navigate the issues surrounding EDC use as they specifically apply to Phase IIIb, Phase IV and other postsubmission trials. Speakers will use real world examples to outline how to make an EDC decision for late phase trials and the differences between pre-approval and post-approval studies – including different EDC requirements for data managers, investigators and other members of study teams. .
CBI’s Forecasting and Budgeting for Global Clinical Trials Conference
September 25-26, 2008, Philadelphia, PA
Session Title: “Forecasting and Tracking Clinical Spend from Country to Country”
Speaker: Lori Shields, Vice President of Operations, Trial Planning Solutions
Date & Time: September 26, 2008 at 8:15 am
When executing a large international or global clinical trial, forecasting can be a challenge because different countries often have different costs and payment schedules. However, with the right tools and practices, sponsors and CROs conducting global clinical trials can analyze costs in different locations and determine their strategy for conducting clinical trials overseas. During this session, Shields will present several templates and tools for managing clinical expenditure across many countries, and teach session attendees how to build cost-efficient global clinical trial studies.
For background information about Medidata executives, please visit http://www.mdsol.com/about/team_management.htm.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading provider of clinical trial solutions that enable the world’s most advanced life science organizations to maximize the value of their clinical research investments by putting powerful tools into researchers’ hands. A pioneer since 1999 in innovative technologies for planning and managing clinical studies – including protocol design; clinical data capture, management and reporting; and trial contracting and negotiation – Medidata Solutions and its global network of business partners address the unique needs of sponsors and sites of all sizes. With deep expertise in conducting studies across all phases and therapeutic areas, on six continents and in more than 80 countries, Medidata Solutions helps clinical researchers reduce trial cycle times, achieve early visibility to reliable clinical data, and maintain strict fiscal responsibility, while safely accelerating the process of bringing lifeenhancing treatments to market.
Contact:
Susan McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com