Beaufort accelerates the validation and market entry of innovative digital health solutions with specialized clinical expertise in software, connected devices, and digital therapeutics.
Our specialized experience spans the complete digital health ecosystem, from mobile medical applications to AI-driven platforms and digital therapeutics, with particular depth in clinical-grade wearables, decentralized trial technologies, and regulated software development.
Our technical expertise encompasses the full range of digital health technologies and regulatory classifications. We understand the unique validation requirements and regulatory considerations for each digital solution category, ensuring appropriately designed evidence generation strategies.
Our extensive experience spans diverse therapeutic applications for digital solutions, with particular strength in behavioral health, chronic disease management, and neurological conditions. We understand the unique patient populations, endpoints, and validation approaches required for each therapeutic area.
From smartphone applications to integrated clinical systems, we tailor validation strategies to your technology’s platform requirements. Our experience across diverse implementation environments ensures appropriate technical validation, usability assessment, and regulatory approach for your specific digital solution.
We guide clients confidently through complex and rapidly evolving regulatory frameworks for digital health products. Our approach aligns evidence generation with specific regulatory requirements to optimize approval timelines while maintaining development flexibility.
Beaufort has been an excellent partner in driving a trial with considerable complexity. We have been impressed with the passion/adaptability of the team and the spirit of continuous learning they bring to the table to drive excellence.
Stay informed with expert perspectives on digital health validation strategies, regulatory developments, and innovative study designs from our specialized digital health team and industry thought leaders.
Get answers to some of the most common questions about digital health clinical validation and CRO services.
The regulatory pathway depends on your product’s functionality, risk level, and intended use. Software as a Medical Device (SaMD) may require 510(k) clearance, De Novo classification, or, in some cases, may qualify for enforcement discretion. Early regulatory engagement is essential for novel digital technologies.
Digital health validation often incorporates usability testing, engagement metrics, and real-world performance alongside traditional safety and effectiveness measures. Studies frequently employ remote data collection, may have faster iteration cycles, and must address unique considerations like algorithm validation and cybersecurity.
Digital therapeutics typically require randomized controlled trials demonstrating clinical efficacy, with endpoints similar to pharmaceutical products in the same therapeutic area. Studies should assess engagement, adherence, and real-world effectiveness alongside primary clinical outcomes.
AI/ML validation requires specialized approaches including algorithm training/testing methodology, dataset curation and validation, performance across diverse populations, and plans for managing continuous learning algorithms and software updates post-approval.
Successful decentralized trials require robust technology selection, participant support infrastructure, data quality monitoring processes, and careful selection of validated digital endpoints. Regulatory acceptance of novel digital measures often requires supplemental validation studies.
Sample sizing considers primary endpoints, expected effect sizes, user variability, and engagement patterns unique to digital interventions. Statistical approaches must account for potentially higher dropout rates but can leverage more frequent data collection compared to traditional studies.
Digital health trials must comply with regional privacy regulations (HIPAA, GDPR), implement appropriate data security measures, address potential cybersecurity vulnerabilities, and maintain transparent data governance practices throughout the product lifecycle.
Acceleration strategies include phased validation approaches, strategic use of real-world evidence, early regulatory engagement, leveraging FDA’s digital health policies, implementing agile clinical development, and designing efficient pivotal studies based on robust feasibility data.
Digital health post-market monitoring often includes analysis of real-world performance data, tracking of user engagement metrics, active surveillance for adverse events, monitoring of cybersecurity threats, and implementing controlled processes for software updates and algorithm modifications.
Digital biomarker validation requires establishing analytical validation (accuracy, precision), clinical validation (correlation with gold standard measures), and demonstrating utility (sensitivity to change, predictive value). Regulatory acceptance typically requires well-designed studies showing correlation with established clinical endpoints.
