PHT and Medidata Provide Sucampo with Integrated eClinical Solution for Pediatric GI Clinical Trial



    PHT Corporation, the market-leading provider of electronic patient
    reported outcome (ePRO) solutions used in more than 300 clinical
    trials worldwide, today announced a new eClinical integration of PHT's
    LogPad(R) ePRO system with Medidata Rave(R) electronic data capture
    (EDC) and clinical data management platform. This new eClinical
    solution has been implemented by Sucampo Pharmaceuticals in order to
    maximize efficiencies for a study of a gastrointestinal (GI) compound
    for the pediatric population.

    This is the first time Sucampo's GI compound is being given to
    pediatric subjects. The company is using PHT's electronic patient
    diaries to follow the safety profile of 120 patients throughout the
    United States. The trial began screening patients last January.

    Sucampo developed a questionnaire that would be easily understood
    by the young age group, and worked with PHT's scientific team to
    implement an optimal eDiary design and minimize respondent burden.
    Patients over 12 years old can complete their diary entries on their
    own, while younger patients who need adult assistance can take
    advantage of PHT's Caregiver Module, which supports authorized
    caregivers who respond on the subject's behalf.

    ePRO data captured by PHT's LogPad System are integrated
    seamlessly with Medidata Rave, thereby providing Sucampo with an
    efficient eClinical trial.

    Glen de Vries, Medidata CTO, said, "Sponsors are increasingly
    leveraging Medidata Rave as an eClinical backbone - a robust platform
    in which data from other clinical trial applications can be collected
    and managed in a single, secure, easily accessible system. Clinical
    trials today require a range of flexible technologies and we are
    pleased to be working with PHT to offer Sucampo a seamless ePRO and
    EDC/CDM solution."

    Phil Lee, PHT President and CEO, commented, "By integrating
    multiple data streams, sponsors are able to take advantage of real
    efficiencies gained by using reliable electronic systems. As a
    founding and active member of CDISC, PHT provides data that are CDISC
    ODM compliant. Therefore, we are able to provide seamless ePRO data
    integration with the Medidata Rave clinical data capture and
    management system in order to enable true eClinical solutions." Mr.
    Lee added, "We are proud to provide Sucampo with a reliable eClinical
    solution as they seek to help children affected by GI issues."

    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
    www.mdsol.com.

    About PHT Corporation

    PHT is the market-leading provider of electronic patient reported
    outcome (ePRO) solutions used in more than 300 clinical trials around
    the world. Our proven LogPad(R) and StudyPad(R) Systems deliver the
    voice of the patient - directly and without distortion - with reliable
    and timely self-reported data. Patient experiences captured firsthand
    by PHT's ePRO Product Suite have been used successfully in at least
    seven known NDA approvals, to date. To learn more about how study
    sponsors worldwide are using ePRO to improve data quality, conduct
    smaller trials, and manage patient safety, enrollment and compliance
    in real time, visit www.phtcorp.com.

    Rave is a registered trademark of Medidata Solutions Worldwide.
    PHT and LogPad are among the registered trademarks and trademarks of
    PHT Corporation. Sucampo is a registered trademark of Sucampo
    Pharmaceuticals, Inc.