CRF Health, a global provider of eCOA solutions for the life sciences industry headquartered in Plymouth Meeting, Pa., has launched a complete TrialMax eCOA solution for diabetes clinical trials. Developed with clinicians and patients to optimize usability and compliance, the solution enables investigators to collect patient reported outcome assessments and deliver defensible data, while minimizing patient and site burden. Already being used in four major global diabetes trials, covering 700 investigative sites and 3,250 patients, the solution offers complete integration between patient eDiary entry and blood glucose measurements.
Diabetes trials often have complex protocols, which can lead to reduced compliance by overburdened patients. CRF Health's diabetes TrialMax Touch eDiary leads patients through data collection in an intuitive and fast way. It has been designed to easily fit into patients' lives while providing more compliant data, as well as increased patient retention. The customizable solution enables features to be added or removed depending on the needs of a particular trial, while the reference diary includes 5/7 data collection points which can easily be adapted. Questionnaires are simple to complete, making participating in a trial uncomplicated for patients.
TrialMax Touch eDiary seamlessly integrates with the Entra Health MyGlucoHealth wireless glucometer, enabling automatic transfer of measurements to a patient's eDiary. The integration ensures complete and accurate data while reducing the risk of transcription errors. Alerts and notifications can be set-up to remind patients to take their medication and test their blood glucose level, while also providing new basal dose directions from the physician in between site visits.
Sites also are made aware of hypoglycemic events via CRF Health's TrialManager, email or SMS in near real time which provides greater opportunity to take appropriate clinical action. The system benefits from the ability to integrate with CRF Health's instrument library, allowing sponsors to electronically incorporate common diabetes instruments into the solution.
"CRF Health's experience in eCOA data collection in diabetes studies gives us a wealth of knowledge and experience in helping customers implement solutions that are not only patient-focused, but that ensure the highest levels of quality data," said Katie Garner, therapeutic areas manager, CRF Health. "Our complete solution for diabetes trials is already being used in four impressive trials due to its unique capability to integrate patient diary entry and blood glucose monitoring, helping to ensure studies run as smoothly as possible, while delivering reliable results."