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.
