Diagnostic Trials

Across the diagnostic device spectrum, PPD’s specialized medical device group provides strategic and clinical trial support for new diagnostic devices and new indications. Our experience includes simple normal and healthy sample collection and rigorous Food and Drug Administration (FDA)-required investigational device exemption (IDE) trials. PPD offers substantial experience in device and diagnostic study execution, strong leadership, and significant regulatory experience with Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety and the Center for Devices and Radiological Health (CDRH).

Our services include:

• Diagnostic device trial strategy and design
• Diagnostic regulatory support
• Protocol development
• Case report form development
• Oversight of central laboratories or sample repositories
• Clinical project management
• Site management
• Clinical monitoring
• Clinical data management (paper and electronic data capture)
• Biostatistics
• Medical writing
• Safety monitoring and management
• Medical monitoring support
• Data and safety monitoring board (DSMB) and clinical events committee (CEC) management
• Quality auditing
• Phase I clinical trial conduct support
• Central laboratory services