CRF Health, the leading provider of patient-centered eSource for the life sciences industry, today announced that its electronic Clinical Outcome Assessment (eCOA) solutions have been selected for a significant insomnia trial by a European pharmaceutical company specializing in the discovery and development of small molecules. The landmark Phase III study involving 5,000 subjects across three continents collects key endpoint data made possible by CRF Health’s TrialMax® platform.
CRF Health will be providing the eCOA solution (TrialMax Touch® and TrialMax Slate®) to all patients in the study for use on-site and via home-based devices, to record both patient and clinician facing assessments. The challenge of a significant and geographically distributed patient population required a high-quality solution that would streamline data collection and provide a high compliance rate, which is achieved through the solutions’ intuitive interface, patient engagement elements and high degree of mobility.
Insomnia is associated with daytime impairment, an increased risk of psychiatric disorders, risk of accident and injury, and is a leading cause of absenteeism and reduced productivity at work. In insomnia trials, self-administered questionnaires at home play a crucial role in gathering endpoint data. eCOA makes it simpler and quicker for patients as it fits seamlessly into subjects’ real lives, guiding them through study protocols, driving high compliance, and generating clean data. CRF Health’s proven track record and unparalleled eCOA expertise gave the sponsor confidence that this important data would be captured in an efficient low risk manner.
“CRF Health prides itself on providing expert advice on both patient and clinician reported outcomes to support central nervous system (CNS) related clinical studies. Our strength comes from not simply handing over devices but supporting study teams and delivering best practice for training and user acceptance,” commented Rachael Wyllie, CRF Health’s CEO. “Our track record of delivering desired outcomes, and appropriate and relevant experience in deploying the required scales for supporting insomnia studies was crucial for the sponsor. “