PHT Awarded CDISC Certification for Archive of Clinical Research Data
ePRO market leader certified by standards consortium it helped found
BOSTON, MA – August 26, 2008 – PHT Corporation, the leading provider of electronic patient reported outcome (ePRO) solutions used in more than 360 clinical trials worldwide, today announced that the Clinical Data Interchange Standards Consortium (CDISC) has certified PHT StudyWorks™ as compliant to their standard. StudyWorks is an online portal for viewing, managing and exporting ePRO data (e.g. patient enrollment, diary compliance, symptom safety) in real time.
PHT is the only handheld ePRO provider to achieve CDISC ODM certification. The certification is for exporting transactional data and metadata in the Operational Data Model (ODM) Versions 1.2 & 1.2.1. Data transfers are an integral part of PHT’s data delivery capabilities and the CDISC ODM standard allows for easy integration into web based Electronic Data Capture (EDC), clinical trial management and statistical analysis systems.
“As a founding member of CDISC, PHT strongly believes in the importance of using standards for clinical research data interchange,” said Phil Lee, PHT President and CEO. “We invested in the CDISC certification because of the value it adds to our clients. Trial sponsors know that seamless data integration with other eClinical systems is yet another advantage to working with PHT.”
PHT recently used the certified ODM export capability to easily integrate data from the LogPad into a leading EDC product. The complete integration took less than one week.
“PHT has always believed in the CDISC mission,” noted Ian McLeod, Vice President of Development at PHT. “The certification is an exciting step in improving medical and healthcare research through information system interoperability achieved by platform-independent data standards.”
About PHT Corporation
Trust your patient and questionnaire data again. PHT is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in more than 360 clinical trials by 90 biopharmaceutical clients. The proven LogPad® System and revolutionary SitePad™ Tablet deliver the voice of the patient, in 80 languages, from homes and sites in 60 countries around the world. By capturing high-quality and time-stamped assessments with minimal respondent burden, transmitted over reliable analog and wireless global technologies, sponsors are able to run smaller and more conclusive clinical research programs. Real-time study management through PHT StudyWorks™ features eClinical data integration, standard and custom data summaries for compliance and enrollment, SafetyPRO™ email alerts, and the industry’s premier study archive. Patient experiences captured firsthand by PHT’s ePRO Product Suite have been used successfully in at least 11 NDA submissions and seven approvals to date. For more information, review interactive product demonstrations at the award-winning www.phtcorp.com.
PHT, LogPad, eSense, SafetyPRO and SitePad are among the registered trademarks and trademarks of PHT Corporation.
Contact: Brenda Nashawaty, bnashawaty@phtcorp.com, 617-688-3253
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