OR WAIT null SECS
announced that the company has recently completed the ePRO vendor certification program for use of the
hronic Pulmonary Disease
ool (EXACT). The EXACT is a patient-reported outcome (PRO) measure designed to standardize the method for evaluating the frequency, severity, and duration of acute exacerbations of chronic obstructive pulmonary disease (COPD) and chronic bronchitis (CB) in U.S., as well as international based studies and clinical trials. Developed by
United BioSource Corporation
(UBC) through a multi-sponsor consortium approach involving input from clinical and methodological advisors and involvement of the U.S. Food and Drug Administration (FDA), the EXACT is a standardized tool for measuring exacerbations of COPD.
CRF Health has achieved certification for two devices currently in use with many ongoing projects; the HTC® HD2 and the HTC® Touch 2, which both use the Windows® Mobile operating system. “This certification allows CRF Health to meet the needs of our client base with regard to using the EXACT measure in their respiratory clinical studies, while giving our sponsor-clients confidence that the data collected via CRF Health’s ePRO solutions will be captured in a consistent and proven manner,” stated John Jordan, Senior VP of eClinical Technology for CRF Health.
When collecting EXACT data, clients have the option of a smaller screen device (HTC® Touch 2) or a larger screen (HTC® HD2), depending on the design of the clinical study and the clients’ preferences.
“We are pleased to certify CRF Health on the electronic delivery of the EXACT and to continue our work with them in the use of the EXACT and other PROs in all types of clinical studies,” said Sonya Eremenco, ePRO Manager at United BioSource Corporation and EXACT Certification Program Manager.