Digital biomarkers are changing the face of clinical trials. By allowing for the collection of high-density data (including during normal daily activities), we can gain new, more powerful insights into the ability of novel agents to modulate or modify disease. Biospective has performed multiple digital biomarker studies for its sponsors, and we have implemented processes for the acquisition, quality control, and analysis of this “Big Data”.
Validation of Novel Digital Health Technologies
Data and Project Management
Deployment of Digital Biomarkers in Multicenter Clinical Trials
Study Protocol Design
Before deployment of novel technologies in later phase studies, it is vital to validate these tools against accepted gold-standards, as well as determine the sensitivity of these putative biomarkers to disease state and progression. Through our CITE™ platform (a network of research centers), we can work closely with technology and pharmaceutical companies to efficiently and cost-effectively test new technologies in healthy subjects and patient populations.
The use of digital biomarkers in multi-center and home-based studies is still relatively new and there are significant challenges. Biospective has gained significant experience with these studies and we utilize our leading-edge, web-based software solution, GRETEL™, to successfully manage these projects and handle the large quantities of data collected. Our Data Science team is also well-positioned to perform advanced analytics of digital biomarker data.