Philadelphia based Bracket , a leading healthcare industry eCOA solutions provider, has announced completion of its e-Diary Certification program with Evidera for the EXACT patient daily e-Diary for Android smartphones and tablets. The certification allows Bracket to standardize its EXACT e-Diary eCOA solution and pass valuable delivery efficiencies to clinical trial sponsors or contract research organizations (CRO), representing an important milestone highlighting the Bracket eCOA solution as the first and as-yet only provider of this instrument to be certified on a tablet device.
The EXACT (the EXAcerbations of Chronic pulmonary disease Tool) is a 14-item patient reported outcome (PRO) daily diary used to quantify and measure exacerbations of Chronic Obstructive Pulmonary Disease (COPD).
COPD is the third leading cause of disease-related death in the US, affecting an estimated 24 million Americans. According to the Centers for Disease Control and Prevention, COPD ranks third (138,080) after heart disease (597,689) and cancers (574,743) as a cause of mortality. The American Lung Association notes that COPD is also a major cause of disability, and while some 12 millions Americans have a formal COPD diagnosis. An estimated 12 million more people may have the disease and go undiagnosed.
Exacerbations are events characterized by an acute, sustained worsening in the patient’s COPD beyond normal day-to-day variability, including an increase in respiratory symptoms such as dyspnea, cough, and sputum production that may require a change in treatment. The EXACT e-Diary is designed to standardize the assessment of the patient’s condition in order to capture this dynamic process.
“Today’s eCOA landscape is very promising,” says Jim Primerano, Senior Vice President and GM, eClinical at Bracket. “The use of ePRO and eCOA solutions in clinical trials has grown in the past 2 years and Bracket sees immense value in providing validated outcomes instruments to facilitate the collection of key trial data. We are very pleased to incorporate the EXACT e-Diary into our ePRO library of instruments, extending more efficiency in delivery of eCOA solutions to our customers.”
Bracket eCOA is a flexible platform for electronic Clinical Outcomes Assessments that collects information from patients (ePRO), clinicians (eClinRO) and other observers (eObsRO). Bracket eCOA has been an integral research tool across a vast number of clinical trials, medication and disease management programs, and comparative effectiveness studies.
Bracket eCOA is the result of forging technological advances combined with an understanding of Bracket clients’ most important objectives. Outcomes are the product of human observation and state-of-the-art reporting, including use of barcode scanning, mobile apps and seamless integration with other programs. The company’s program designs have put Bracket at the forefront of electronic Clinical Outcomes Assessments.
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Evidera, a wholly owned subsidiary of Symphony Technology Group, provides health economic, outcomes research, market access, data analytic and epidemiology services to life sciences organizations worldwide. For more information, visit: