The validation of digital measurements as biomarkers or clinical outcomes assessment (COAs) and their acceptance or qualification as endpoints are critical for the successful integration of digital health technologies into clinical development and achieve their potential of accelerating availability of new treatments At confinis, we offer expert support in developing validation and qualification strategies for digital biomarkers, COAs and endpoints. Our team provides guidance on study design, data collection, and analysis methods, ensuring that digital measurements are robust and reliable.

We work with clients to develop comprehensive strategies that meet regulatory requirements and demonstrate the value of digital health technologies in pharma or medical device clinical development. Our expertise in digital health and regulatory compliance, and our knowledge of the clinical development space, helps clients successfully navigate the complexities of digital measurements validation and qualification, ensuring that their technologies are ready to be deployed succesfully in clinical trials.