Reliable ePRO and EDC data used to evaluate safety and efficacy of
BOSTON, August 28 /CNW/ - 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.
For further information:
For further information: Lois Paul & Partners Susan Lombardo,