IMARC is a leading clinical research organization that specializes in ensuring compliance at every stage of an investigational study, from clinical planning to study closeout. Learn more about how our process protects the integrity of your study and enhances your team’s efficiency.
This whitepaper will explore the role the FDA has played, and will continue to play, in regulating in vitro diagnostic devices. It will examine the three groups of in vitro diagnostic devices: Analyte Specific Reagents (ASRs), Laboratory Developed Tests (LDTs) and In Vitro Diagnostic Devices (IVDs).
IMARC offers a comprehensive package of services to complement your team at every stage of your clinical trial, from planning to closeout. Learn more about how we help your team achieve its goals.