As a Contract Research Management Organization, IRC provides clinical trial management services with a highly qualified staff of physicians, pharmacologists, pharmacists, nurses, biostatisticians and monitors serving niche and emerging pharmaceutical, biotech and medical device organizations. A particular area of focus with significant expertise is on combination products.
We offer a comprehensive scope of services for Phase I, II and III studies with experience in a wide area of medical and multi therapeutic disciplines. Our services are personalized and highly responsive to fit your needs with the flexibility to with work with your staff or provide "turn key" results. IRC is unlike your typical CRO. The services we provide in the clinical arena are highly cost effective.
CRO / CMO SERVICES
- Pre-clinical design and data review
- Study Protocol Design
- Investigator Brochure Design and Development
- Study Site Selection and Qualification
- Pre IND / IDE Regulatory Meetings
- IRB / Ethics Committee Submissions
- Regulatory Submission/Approval
- Study Site Training and Initiation
- Study Site Monitoring
- Data Acquisition/Analysis
- Medical Safety Monitoring
- Independent Medical Safety Committee Review
- Regulatory Reporting