eClinicalHealth, a cloud-based remote clinical research technology company, and Chilli Consultancy, a statistical and patient-centered outcomes consulting firm, announce new streamlined clinical outcome assessment (COA) development services.

iUsability, a new service to be jointly offered by eClinicalHealth and Chilli Consultancy is a novel patient usability testing service. The Integrated Usability Service or iUsability streamlines the necessary testing of patient reported outcomes (PRO) instruments and other clinical outcome assessment (COA) instruments when migrating from paper to electronic formats (ePRO).

The iUsability service optimizes the usability of patient-facing eClinical solutions as well as capturing feedback from all trial stakeholders. Novel aspects of this service include a focus on Bring Your Own Device (BYOD) methods that allow patients to use their own existing devices to enter data, as well as the vendor- and device-agnostic approach, which allows the usability testing results to be shared with other companies in the industry. These approaches reflect the future of data capture in clinical trial settings and promote better information sharing in the industry eliminating the current practice of repeated testing of the same instruments.

“The iUsability service fills a void in the eCOA marketplace. Many people own multiple internet-enabled devices. Allowing patients to use their choice of device is very important, it helps avoid compliance issues, reduces patient burden and saves our Sponsors tremendous amounts of money using a future-proof solution. With Integrated Usability Service, we can optimize design to capture the evidence that the instrument’s scientific integrity is maintained when compared to the paper version,” said Kai Langel, co-founder and director of Technology and Patient Solutions at eClinicalHealth.

Another new service jointly offered through eClinicalHealth and Chilli Consultancy is eValidatePRO, which is a remote approach for conducting psychometric validation studies for Clinical Outcomes Assessments (COA/eCOA). Regulators required outcomes assessments for labeling claims to be developed using a rigorous process that includes assessment of the psychometric properties of an instrument prior to the pivotal trial. Since these studies are often on the critical path, eValidatePRO’s remote methodologies streamline this process without sacrificing scientific rigour.

“While the qualitative stages of instrument development are conducted in-person using in-depth interview methodologies with smaller samples of participants, the psychometric validation stage requires much larger populations to complete the new instruments to ensure statistical rigor. Being able to do this remotely, in a quick and efficient manner, importantly decreases the time needed for instrument development. Using remote research for this stage of the instrument development is a real breakthrough in research methodology,” said Dr. Annabel Nixon, co-founder and director at Chilli Consultancy.

For biopharmaceutical companies that are looking for better ways to conduct outcomes instrument development projects, the partnership between eClinicalHealth and Chilli Consultancy combines modern Clinpal technology and remote research expertise with years of PRO, scientific and statistical experience.