Helping Your Diagnostic Clinical Trial Reach Its Full Potential
Medpace helps accelerate the advancement of in-vitro diagnostics (IVD) and other diagnostic tools with a comprehensive offering of services and expertise:
- Strategic regulatory affairs leadership provides early guidance and execution for developing diagnostics
- Specialized medical expertise in key areas of development including hematology and oncology, infectious diseases, and gene and cell therapies
- Protocol development, and high-volume site and investigator selection sets the stage for enrolling large patient populations
- Experience with varied medical settings including bed-side, laboratory or other healthcare professional settings
- Wholly-owned Central Laboratories and Bioanalytical Laboratories provide integrated biomarker research support
- Development and validation of diagnostic assays for use in clinical trials
- Sample management
- Relationships with specialized genomics labs
Precision Medicine – Companion Diagnostics
Matching the right drug to the patient based on each person’s biological makeup is the foundation of precision, or personalized medicine. A companion diagnostic – defined as “an in vitro device that is essential for the safe and effective use of a drug” is the backbone of identifying those matches. Typically classified as Class III devices, companion diagnostics require more rigorous regulatory controls that can increase complexity, extend timelines, and add costs.
Given these added complexities, it is critical to partner with a CRO with the medical and regulatory leadership who can help navigate to success with your diagnostic clinical trial.