Koneksa is leading the revolution in digital biomarker development. We provide standard and customized digital biomarker and measure solutions in conjunction with a robust end-to-end data integration platform. We have a proven record of developing innovative algorithms, and delivering high-quality data from validated measures. Our science-driven approach simultaneously lowers patient burden in clinical trials and speeds clinical study conduct as well as data collection, shortening the path to mission-critical milestones.
Biomarker development follows standard steps, as shown in the digital biomarker and measure pipeline, and summarized as 1) concept creation/sensor verification, 2) analytical validation, and 3) clinical validation. These steps are based on the work of the the scientific community, such as frameworks from the FNIH Biomarker Consortium’s qualification evidentiary criteria and the verification, analytical validation, and clinical validation (V3) steps, as well as regulatory documents, including Biomarker Qualification Evidentiary Framework and Digital Health Technologies Remote Data Acquisition In Clinical Investigations by the FDA.
From oncology to neuroscience, Koneksa is advancing clinical research by developing, validating, and deploying digital biomarkers . Check out our clinical pipeline and see for yourself.