FOR IMMEDIATE RELEASE
Medidata Executives Join Pharma Leaders to
Discuss Global EDC Principles and Adaptive Trial Designs
NEW YORK, NY – October 30, 2006 – Medidata Solutions executives continue to drive discussion around critical topics in the e-clinical space at key industry events throughout November. Co-founder and Chief Medical Officer Ed Ikeguchi, Vice President of Development Keith Howells and Senior Business Consultant David Quarm will each be leading discussions at upcoming conferences next month, while Co-founder and Chief Technology Officer Glen de Vries will be participating in a webinar series.
In November, Medidata executives will deliver the following four presentations:
DIA Multi-Track Conference on CDM, eClinical & Clinical Research
“The Changing World of Clinical Trials”
Nov. 5–8, 2006—Switzerland
Role of People in eClinical
Nov. 7, 2:00 p.m.
In this joint session, David Quarm will discuss “EDC—Formulating a Global Understanding,” while taking a look at how new technologies are not only affecting how people work, but also who they are. At any given time, people carry one or more of the following devices: a GSM, PDA, Blackberry, Digital Pen, Bluetooth Headset or other mobile devices. To be connected to family or work is no longer dependent on distance. Similarly, not only have tools changed the way we conduct a clinical trial; our working processes and our skills have adapted as well. During this session, speakers from Blue Linea (France), Technology Limited (UK) and Fulcrom Pharma Developments (Bulgaria) will join Quarm in assessing how clinical teams use new technologies as tools to improve their own effectiveness in the conduct of clinical trials.
DIA Multi-Track Conference on CDM, eClinical & Clinical Research
“The Changing World of Clinical Trials”
Nov. 5–8, 2006—Switzerland
Practicalities of Managing EDC Studies
Nov. 8, 11:00 a.m
Ed Ikeguchi will discuss “EDC around the Globe—The Reconciliation of Clinical Research Functions” in this joint session on how EDC systems are rapidly evolving as advances in technology offer more elegant solutions. This trend presents continuous challenges to practitioners as they have to balance embracing new technologies with the efficient execution of their clinical programs. Ikeguchi, along with industry leaders from Astellas Pharma GmbH (Germany) and Serono International (Switzerland), will focus on how clinical operations can achieve the ideal balance and progress at an optimal place.
SCDM Good Clinical Data Management Practices (GCDMP) Webinar series
Electronic Data Capture (EDC) Principles
Nov. 9, 2:00–3:30 p.m.
Registration: http://www.scdm.org/events/gcdmp2006/
As a member of the SCDM EDC task force, Glen de Vries will join Debra Jendrasek, manager of US EDC Solutions Chiltern International, to discuss the importance of standard principles as they become critical to the success of the implementation of EDC and associated technologies. As EDC becomes widely adopted in companies small and large, it’s time to concentrate on ways to establish an environment conducive to incorporating EDC into the clinical trial process from the viewpoint of data management.
CBI’s Clinical Trial Technology and Data Management Conference
Nov. 16–17, 2006—West Conshohocken, PA
Adaptive Trial Designs—Eliminating the Uncertainty by Addressing FAQs
Nov. 17, 10:15 a.m.
In this session, Keith Howells will join panel moderator Jerald Schindler, president of Cytel Corporation, to discuss eliminating the uncertainty in adaptive trial designs. Adaptive trial designs enable investigators to analyze data while a trial is in progress, generating a number of benefits, such as cost savings from shorter timelines and earlier detection of adverse events. This panel will address some of the most commonly asked questions:
- How do investigators understand a data management organization and how it is evolving?
- How do investigators get the data?
- What do investigators do with the data once it is received? How do they clean the data?
- How do investigators respond to novel things that are happening?
About David Quarm
With more than 11 years of data management and contract research organization (CRO) experience, David joined Medidata Solutions as a senior business consultant. Before joining Medidata, he spent more than 10 years with a CRO specializing in Electronic Data Capture and eClinical technologies.
David is a frequent presenter at DIA, CDISC and eClinical conferences, as well as chair of the Association for Clinical Data Management (ACDM) EDC Special Interest Group.
About Ed Ikeguchi
As one of Medidata Solutions’ founders and the company’s chief medical officer, Ed focuses on regulatory affairs as well as 21 CFR Part 11 and developing strategies in emerging global markets. Ed has secured patents on Medidata Solutions’ clinical trial technology and also invented several patented medical devices used in the clinical development process.
Ed served as assistant professor of clinical urology at Columbia University and has firsthand experience using healthcare technology solutions as a clinical investigator in numerous trials sponsored by both commercial industry and NIH. He has expertise in technology-based process evaluation and value modeling for the pharmaceutical and biotechnology industries.
A frequently featured presenter at industry and academic events, Ed spoke at the Drug Information Association (DIA) Annual Meeting, DIA Annual Workshop in Japan for Clinical Data Management, the Society of Clinical Data Management (SCDM) and the Outsourcing of Clinical Drug Development Conference.
About Glen de Vries
Glen is one of the founders of Medidata Solutions and has filled the role of chief technology officer since 1999. He is the lead architect of the Medidata Rave system, and has grown Medidata’s Research & Development team to include top talent from the clinical research community, banking and enterprise resource planning industry.
Prior to his work with Medidata Solutions, Glen’s pioneering efforts in online physician/patient relationships were featured by The New York Times and drew the attention of the Office of Health and Human Services. He has more than 10 years of experience in medical software development, including Electronic Health Records and consumer-targeted products.
Glen was a featured presenter at multiple Drug Information Association (DIA) meetings in the U.S., as well as DIA Japan, SCDM, Bio-IT World, BIOPHEX, Partnerships with CROs, the National Medical Association Annual Meeting and American Urological Association Annual Meetings.
About Keith Howells
Keith has dedicated his efforts to the clinical trials business for more than 15 years and currently manages the development team at Medidata Solutions. He is responsible for both the core Rave product as well as customer-specific integrations and utilities. In this role, Keith drives the innovation of new features and technologies into Rave, while providing a smooth upgrade path for existing customers.
In his prior position at Oracle, he helped establish Oracle Clinical as the dominant back-end data management system, initially as head of the pharmaceutical consulting practice and then as vice president of the pharmaceutical applications development group.
Keith is also a frequent presenter at a number of industry conferences, including various user group meetings and the annual conferences for the Drug Information Association and the Society for Clinical Data Management.
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 lifeenhancing treatments to market—on five continents and in more than 70 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