For in vitro diagnostic (IVD) research, Beaufort maximizes operational excellence and regulatory success by providing more specialized expertise than any other CRO can offer. Since our founding, Beaufort maintained a central focus on IVD development, which underscores the tested, proven solutions we provide today. We offer considerable experience across a wide array of IVD assays, including:
- Personalized medicine
- Molecular diagnostics
- Conversion of laboratory developed tests to globally regulated diagnostic assays
No other partner can provide the level of operational and regulatory awareness that Beaufort does. We improve IVD research performance through a deep understanding of the requirements and nuances of diagnostic studies, and deliver better overall project management and service in terms of the quality, speed and value realized.
The Beaufort Team Will:
- Design protocols and study plans to maximize project viability
- Evaluate investigators and sites to identify those with the most relevant expertise and serviceability
- Establish data collection and management plans for better control and quality
- Develop effective submission and negotiation strategies to reduce time to market
- Provide regulatory support for PMAs, pre-submissions, IDEs, 510(k)s and EU technical files
Clinical and Regulatory Services
Beaufort will develop a regulatory strategy and clinical trial blueprint specifically for your IVD assays or instrument platforms and follow through with precise execution to ensure you don’t hit unnecessary delays or setbacks. We specialize in comprehensive study management and monitoring and will set a sound regulatory strategy to provide a foundation for successful health care innovation, especially for sophisticated and novel IVD products facing evolving regulations. Beaufort excels in regulatory interaction and representation, and we’ll find the optimal way to support new product development and/or marketing claims to maximize commercial potential.
Beaufort provides unparalleled expertise in quality assurance services for in vitro diagnostic development. With operations that span the globe, we have the people and capabilities to establish quality and offer services that go beyond establishing mere compliance — from quality system audits to production and process controls to supplier management, Beaufort’s services cover all aspects of quality assurance and compliance to help you successfully take a new product to market or maintain the quality of existing products.
Beaufort delivers IVD veterans for in vitro diagnostic companies worldwide and maintains a network of well-vetted in vitro diagnostic CRAs, regulatory affairs and quality assurance professionals for placement at every level. Our network spans more than 25 countries, and with several staffing models — from functional outsourcing and staff augmentation to contract or permanent placement solutions — you can trust Beaufort to solve your staffing challenges.