An integrated suite of eClinical tools for cardiometabolic clinical trials
Winston-Salem, NC – Clinical ink, a global life science technology company, today announced the launch of GlucoseReady™, a fully integrated GCP compliant digital platform designed for the new era of cardiometabolic clinical trials. The suite of tools includes disease specific electronic clinical outcomes (eCOA) assessments, behavioral assessment by the SPUR™ tool, lifestyle standardization, blood (BGM) and continuous glucose monitoring (CGM), digital weight scale and actigraphy. Unique endpoint features include ability of BGM and CGM to trigger hypoglycemia eCOA within the platform in line with the latest FDA guidance. Novel compliance features include prediction, tracking and prevention of non-compliance and drop out at site and patient level. Partnerships with leading digital device developers further reinforce alignment with FDA expectation for regulatory compliance.
GlucoseReady™ provides modules which used separately or together support multiple therapeutic areas including diabetes, chronic weight management and obesity and NASH/MASH, within a single GCP platform designed for user friendliness, patient support as well as the requirements of an FDA inspection.
Jonathan Goldman, MD FACC FRCP, CEO of Clinical ink commented: “The next generation of Cardiometabolic trials require a new approach to understanding who the patients are and what they care about. GlucoseReady™ is designed from the ground up to provide full real time transparency into patient behavior and lifestyle whist capturing the full range of relevant symptoms, signs and biomarkers. We believe these user friendly tools can support the relationship between site and patient to improve the most important variable of all: retention. In addition, near real time data visualization provides sponsors with a new gold standard for data science.”
About Clinical ink
Clinical ink is the global life science company bringing together data, technology, and patient-centric research. Our deep therapeutic area expertise, coupled with Direct Data Capture, eCOA, eConsent, Telehealth, and Digital Biomarkers advancements, including the use of Continuous Glucose Monitoring for the detection of hypoglycemia, support the next generation of clinical trials and, ultimately the clinical management of patients.