CRF Health Demonstrates Equivalency of eCOA Solution for COPD Trials

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Company News Release

Plymouth Meeting, PA – September 30, 2015:  CRF Health, the leading global provider of eCOA solutions for the life sciences industry, today introduced an eCOA solution to eliminate data collection challenges and reduce patient burden in Chronic Obstructive Pulmonary Disease (COPD) trials. Patient-tested, CRF Health's complete TrialMax® eCOA solution provides electronic versions of the St. George's Hospital Respiratory Questionnaire for COPD patients (SGRQ-C) and the COPD Assessment Test (CAT) which have been demonstrated to be easy-to-use and provide comparable data to their paper originals. The result is an eCOA solution that brings together activity monitor data, patient-reported outcome and symptom data to deliver the clearest overview of a patient's condition.

The SGRQ-C and CAT instruments have undergone electronic equivalence testing on CRF Health's TrialMax Slate® site-based eCOA solution to demonstrate that the questionnaires are interpreted and responded to in the same way as their paper counterparts. For sponsors, CRF Health's validation testing means they can utilize the resulting equivalency report as part of their overall regulatory submission, removing the time and expense required to conduct a standalone equivalence study themselves.


"Our experience of collecting clinical outcomes assessment data in over 30 COPD trials has demonstrated the need for tools that make the process as burden-free and simple for patients as possible. CRF Health's COPD solution allows investigators to concentrate their attention on what matters most, their patients, by making it possible to leverage key COPD instruments and easily monitor exacerbations", comments Paul O'Donohoe, Director of Health Outcomes at CRF Health. "We are now pleased to be able to share the evidence of our equivalency testing with customers which will simplify the process of their regulatory submissions."

With a patient population struggling with lowered energy levels, reduced compliance in COPD trials can become a prevalent issue due to the large burden placed on patients to report their symptoms and complete patient reported outcomes. The TrialMax solution utilizes a patient-friendly electronic diary to monitor exacerbations and minimize the burden on sick patients, while achieving a more complete data set through better compliance.

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