Medidata Solutions, invivodata and CDISC to Present DIA-Sponsored Webinar on ePRO and EDC Integration

    TORONTO, June 1 /CNW/ - Medidata

    WHO:  Dave Iberson-Hurst, Founder of Assero Limited, Vice Chair of the
          European CDISC Coordinating Committee, and CDISC ODM Team Lead

          Hugh P. Levaux, Ph.D., Vice President of Product Strategy, Medidata

          Bob Young, Senior Vice President, invivodata inc.

    WHAT: "An Integrated Approach: Combining ePRO and EDC"

    Sponsors today are recognizing the growing need to move towards more
holistic, end-to-end clinical processes and are making investments in
integrated approaches to clinical trial technology that can enable dynamic
decision-making and reduce risk, redundancy and cost. Hosted by the Drug
Information Association (DIA), this webinar will introduce how sponsors can
leverage industry standards to share data across electronic patient reported
outcomes (ePRO) and electronic data capture (EDC) systems for a unified view
of trial progress.

    Presenters will discuss integrating ePRO data recorded using handheld
electronic patient diaries with Case Report Form (CRF) data captured with EDC
systems - and how it all can be viewed by clinical trial personnel in one
system. By providing real-time web-based access to integrated
patient-generated data and case report form data, sponsors can quickly and
easily access more comprehensive data, increase trial efficiencies and improve
patient safety. Additionally, webinar attendees will learn how integrated
solutions can leverage CDISC ODM standards and be fully validated, 21CRF part
11-compliant and quickly configured to meet the needs of each trial protocol.

    WHEN: Monday, June 11th, 2007, 11:00 a.m. - 12:30 p.m.

    WHERE: To participate in this web conference, please register at:
productID=14253&eventType=Webinar (Due to the length of this URL, it may be
necessary to copy and paste it into your Internet browser's URL address field.
You may also need to remove an extra space in the URL if one exists.)

    About Dave Iberson-Hurst, Founder of Assero Limited, Vice Chair of the
European CDISC Coordinating Committee, and CDISC ODM Team Lead

    Dave Iberson-Hurst is founder of Assero Limited with 25 years experience
in computer system development. Before founding Assero, Dave spent three years
as chief technology officer for a start-up company developing Electronic
Patient Diary systems for clinical trials. He has since founded Assero to
focus on the use of CDISC data interchange standards, developing tools for use
with the Operational Data Model (ODM), consulting on the e-Clinical vision and
the use of the ODM and the other CDISC standards across the clinical trial
enterprise. Dave is active within CDISC and has recently been appointed as the
team lead of the ODM Modeling Team. He is Vice Chair of the European CDISC
Coordinating Committee (E3C) and a member of the CDISC Technical Advisory
Committee (TAC). He is also a member of the programme committee for the 2008
(and for those held since 2004) CDISC Euro Interchange. Dave is co-lead of the
CDISC electronic Source Data Interchange (eSDI) group that is working with the
Food and Drug Administration (FDA), examining the difficult topic of
electronic source documents and data. Dave is a frequently published author
and has presented at conferences on the topics of the regulations, the use of
the CDISC standards and has been responsible for the development of the CDISC
e-Clinical end-to-end workshops held over the last few years. He has also
co-presented a number of e-Clinical Trial workshops at recent DIA conferences
and undertakes ODM training on behalf of CDISC. For more information, please
visit or

    About Hugh P. Levaux, Ph.D., Vice President of Product Strategy, Medidata

    As Vice President of Product Strategy at Medidata Solutions, Hugh handles
the overall definition and management of Medidata's product offerings, working
to bring together Medidata Rave implementation, hosting and support services
to address new and existing market segments and customer requirements. With 15
years of experience in pharmaceutical outsourcing, strategic consulting and
health outcomes research, as well as expertise in early phase clinical
development, late phase registries and safety surveillance programs, Hugh most
recently served as CEO of Ninaza. While at Ninaza, a recent provider of
web-based electronic data capture (EDC) solutions, Hugh set the strategic
direction for the company, in addition to managing its daily operations, with
a specific focus on product development, commercial operations and
professional services. Prior to his employment at Ninaza, Hugh was the vice
president and general manager of the pharmaceutical and biotechnology practice
at CareScience, a supplier of web-based patient database and analysis
software. He also served as senior vice president at Quintiles Transnational,
where he directed international late phase sales and clinical operations.

    About Bob Young, Senior Vice President -- invivodata, inc.

    Bob Young is Senior Vice President of Sales & Marketing at invivodata. In
his role, he directs product planning, strategic alliances, and customer
relationship management. Mr. Young has over 21 years of experience in
marketing, product development and delivery, customer service, and project
management for software, hardware, and networking companies in a broad range
of industries. He has spent the past seven years focused on the delivery of
behavioral science-based services and technology to support Patient Reported
Outcomes (PRO) research for life sciences companies. Mr. Young also currently
holds the position of President of PRO Consulting, a division of invivodata,
where he directs the product and service strategy, organizational development,
and client relationships related to science-based advisory services relating
to the collection of data from patients in clinical research. For more
information, please visit

    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

For further information:

For further information: Lois Paul & Partners Susan Lombardo,

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