Applying Clinical Insights to Digital Health Innovation
As digital health transforms clinical research, sponsors need partners who understand both cutting-edge technology and the intricacies of clinical trial execution. The DCRI brings together clinical expertise, regulatory insight, and technological solutions to bridge the gap between theoretical potential and clinical application.
Our unique position as an academic research organization with deep industry partnerships allows us to provide unbiased evaluation while understanding commercial realities. We've built our reputation on delivering rigorous evidence that supports regulatory submissions, market access decisions, and clinical adoption.
Comprehensive Digital Health Capabilities
Clinical Research Excellence
- Wearable technology validation across therapeutic areas, including cardiology, pulmonology, and sports medicine
- AI algorithm evaluation and clinical decision support system validation
- Digital endpoint development for traditional and novel outcome measures
- Decentralized clinical trial design leveraging digital tools for enhanced participant engagement and data collection
Strategic and Regulatory Guidance
- Regulatory pathway consultation for digital therapeutics and medical devices
- Evidence generation strategy tailored to your product's regulatory and commercial goals
- Health economics and outcomes research demonstrating real-world value
- Digital health policy expertise navigating the evolving artificial intelligence regulatory landscape
Technology Integration and Analysis
- Digital platform evaluation assessing usability, reliability, and clinical utility
- Data integration and analytics, combining traditional clinical data with digital health measurements
- AI model development and validation, ensuring robust performance across diverse populations
- Cybersecurity and privacy assessment meeting healthcare data protection standards
Digital Health Innovation in Action
The DCRI actively deploys and tests technologies in clinical settings to understand their practical impact and the challenges they may present. Our team serves as a trusted broker for artificial intelligence-driven technologies and digital therapeutics, combining clinical expertise with advanced technical skills to transform digital concepts into reliable, evidence-based solutions.
Our portfolio of innovation includes:
- AI validation and clinical decision support: Developing comprehensive evaluation frameworks to assess and validate AI outputs during product development, ensuring that artificial intelligence tools meet the highest standards of clinical accuracy and safety before reaching patients and health care providers.
- Digital biomarker development: Pioneering the integration of digitally derived biomarkers as endpoints in clinical trials, leveraging continuous data streams from wearable technologies and sensors to capture patient outcomes with precision and frequency.
- Remote patient monitoring solutions: Advancing decentralized clinical trial methodologies through sophisticated data integration from wearable devices and remote monitoring systems, significantly improving patient retention rates while reducing missing data points critical for regulatory submissions.
- Military and government partnerships: Collaborating with the Uniformed Services University on innovative wound closure algorithms that analyze wound effluent to guide clinical decision-making, demonstrating our ability to tackle complex healthcare challenges across patient populations and care settings.
- Digital therapeutic validation: Supporting the regulatory pathway for prescription digital therapeutics, including game-based interventions for pediatric ADHD treatment, through the evolving landscape of software-as-medicine approvals.
- Organizational AI integration: Leading DCRI internal initiatives to responsibly integrate AI into clinical research operations, and training faculty and staff, while establishing institutional frameworks that ensure ethical and effective use of AI technologies across all DCRI programs.
Thought Leadership and Clinical Insights
Our clinicians work with digital health tools daily in the service of their patients, providing real-world insights that traditional contract research organizations cannot offer. This ensures that every study we conduct contributes to the evolving digital health landscape through research, regulatory guidance, and clinical practice integration. Discover how our experts are shaping the way we think about and implement these solutions.
Wearables in Clinical Research: Data, Trends, and Challenges
Beyond the Endpoint Podcast
Marat Fudim, MD, MHS, discusses the potential of wearable technology from the perspective of healthcare providers and researchers. What impact could this technology have on health monitoring? And how are these devices and the data that they generate perceived by healthcare professionals?
Striking a Balance: Innovation, Equity, and Consistency in AI Health Technologies
Journal of Medical Internet Research
Inconsistent oversight can create unfair advantages for some innovators while potentially hindering life-saving solutions from established healthcare companies. The authors propose a new regulatory evidence framework designed to create a level playing field for all AI medical device manufacturers while ensuring transparency and safety for patients and clinicians.
Strategic Partnerships Driving Innovation
The DCRI's collaborative approach spans academic institutions, technology companies, pharmaceutical organizations, and healthcare systems, fostering a comprehensive ecosystem for digital health advancement.
Duke University Partners
- Duke AI Health - Advancing AI applications in healthcare
- Duke Heart Center - Cardiovascular digital health innovation and implementation
- Duke Department of Population Health Science - Real-world evidence and health outcomes research
- Duke Margolis Center for Health Policy - Digital health policy and regulatory science
- i-Cubed - DCRI's center for clinical research innovation
Industry Collaborations
We work with emerging digital health companies, established pharmaceutical organizations, medical device manufacturers, and technology leaders to validate solutions and generate evidence for regulatory and commercial success.
Professional Organizations
- Clinical Trials Transformation Initiative (CTTI) - Advancing clinical trial modernization
- Digital Medicine Society (DiMe) - Setting standards for digital health technologies
