Working with your company IRC provides for a strategic analysis of your project to develop a meaningful and realistic plan defining goals and objectives. Our strategic analysis includes a risk assessment and alternatives to be considered by your organization.
Defining a clear plan and understanding in meeting your project needs is results oriented and leads to achieving your objective. Evidence of this approach is the high degree of satisfaction and the long term relationship IRC has developed with our clients.
The core services provided by IRC include:
Supplementing your existing regulatory department needs in variety of compliance areas and includes product dossiers and submissions for review and approval by the authorities such as FDA.
- Clinical trial management
Clinical trial management with protocol development, site selection, IRB and Ethics Committee review, regulatory documentation preparation and submission, site training and initiation, data management and monitoring, through closure.
- Quality systems services
Quality systems services under U.S. QSR, U.S. cGMP, ISO 9001 / 14385 to ensure compliance in manufacturing and marketing.
- Personnel training
Personnel training either dedicated or along the way as required in each of the core disciplines under the IRC umbrella.