Where Clinical Research Is Heading — and How We Design for It
Our research interests sit at the intersection of applied public health and digital health innovation, with a particular focus on cardiometabolic health literacy and self-advocacy. Below is a general overview of the research approaches and regulatory context we design around — not a description of any single, currently unreleased program.
Decentralized & Hybrid Study Designs
Trial design has shifted decisively toward hybrid models that combine limited in-person site visits with remote data collection — roughly 78% of clinical trials now incorporate decentralized elements, up from about 36% in 2020, and well-designed hybrid approaches have reported 25–40% improvements in participant retention. Regulators have kept pace: the FDA issued its most comprehensive guidance yet on decentralized trial expectations in September 2024. We design protocols that use this hybrid structure deliberately, reserving in-person contact for what genuinely requires it.
Sources: Sakara Digital, "Decentralized Clinical Trials in 2026" · PMC, sensor-based digital health technologies in clinical trialsTelehealth & Virtual Studies — Social and Behavioral Outcomes
Measuring knowledge, attitudes, and behavior change remotely requires different methodological discipline than an in-clinic assessment. A 2024 methods review in JMIR Research Protocols examined a decade of real-time virtual data-collection studies and distilled best practices for live, two-way remote research interactions — a useful foundation for studies measuring social and behavioral outcomes over telehealth rather than in person.
Source: JMIR Research Protocols, "Protocol for Virtual Data Collection Studies," 2024Telemetry & Real-World Engagement Data
Sensor-based and passive-monitoring technologies increasingly appear in natural-history and interventional studies, capturing frequent, real-world measures that are difficult to obtain from in-clinic visits alone — improving statistical power and participant retention while reducing travel burden. The same principle extends to software-based tools, where usage and engagement telemetry can serve as a complementary outcome signal alongside traditional pre/post measures.
Source: PMC, "Implementing sensor-based digital health technologies in clinical trials"Software-Based Interventions & the Evolving Regulatory Context
The regulatory treatment of standalone health software (Software as a Medical Device, or SaMD) continues to evolve. The FDA withdrew its 2017 "SaMD: Clinical Evaluation" guidance in January 2026, and SaMD itself remains defined broadly by international regulators as software that performs a medical purpose independent of hardware. We help teams position and evaluate software-based health tools carefully within this shifting landscape — including the distinction between general-wellness/educational framing and device-adjacent claims — rather than assuming a fixed regulatory answer.
Sources: Hale Consulting Solutions, FDA SaMD guidance withdrawal, Jan. 2026 · FDA, Software as a Medical Device (SaMD)Interested in Partnering on a Study or Clinical Site Collaboration?
We welcome conversations with sponsors, co-investigators, and funders.