At Beaufort, we bring distinctive expertise to emerging and cutting-edge healthcare technologies that require unique clinical, regulatory, and technical approaches. Our teams understand the distinct challenges of these innovative areas and provide tailored solutions that accelerate development while navigating complex regulatory landscapes.
Our specialized teams work alongside developers of the most advanced healthcare technologies, providing strategic clinical validation support tailored to each unique platform. Get the regulatory insight and clinical expertise you need to bring breakthrough solutions to the finish line.
Beaufort offers the expertise, insight, and flexibility to help you navigate complex healthcare technology development and validation challenges with confidence.
Beaufort guides AI-powered healthcare solutions through the intricate challenges of clinical validation and regulatory approval. Our knowledgeable teams develop tailored approaches for algorithm training and testing, dataset validation, performance across diverse populations, and strategies for managing continuous learning systems. We stay at the forefront of evolving regulatory frameworks for AI/ML technologies
Our precision medicine authorities design studies that establish the clinical validity and utility of personalized therapeutic approaches. From biomarker identification to treatment response prediction, we implement customized protocols that address the particular statistical challenges and regulatory considerations of personalized medicine interventions.
Beaufort’s technical teams understand the complexity of validating NGS technologies and applications. We design studies that establish analytical performance, clinical validity, and clinical utility while navigating the evolving regulatory landscape. Our proficiency spans targeted panels, whole genome approaches, and innovative NGS applications across various disease categories.
Our global CDx strategists navigate the intricate coordination between diagnostic and therapeutic development programs. We implement integrated approaches that address the distinct regulatory requirements and development timelines for combination products. Our experience includes early biomarker identification, assay development support, and pivotal validation studies for various CDx technologies.
Beaufort provides comprehensive support for developers of MRD technologies across various oncology applications. We understand the challenges of establishing clinical validity, determining appropriate cutoffs, and demonstrating prognostic value. Our teams design studies that address the specific specimen requirements, reference method selection, and statistical methodologies critical for successful MRD validation.
Contact our team to explore how our expertise can accelerate your development timeline and optimize your path to market.
