Doing Diagnostics Right by Redefining Clinical Studies
We streamline and expedite the IVD clinical research process, leveraging our regulatory expertise and curated site network to help bring your IVD test to market faster and more efficiently.
Our Services
Study planning and execution from start-up to closeout
Protocol design and development
Real-time study updates and all data in one system for efficient tracking: - eConsent, eSource, eTMF, EDC, and project planning
Real time data dashboard
Curated IVD site network with embedded study coordinators
Supply management
Data analysis and clinical study report writing
Regulatory submission and agency communication
IVD reference laboratories for comparator testing