Find out what sponsors need to plan for when designing Bring Your Own Device (BYOD) clinical studies, capturing more representative, free-living participant data without the biases of single-timepoint clinic visits.
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Explore why inconsistent definitions of adherence across biometric monitoring technology studies make it harder to trust clinical trial data, and what standardized reporting could change.
See why cat-allergic asthmatics who live with a cat needed significantly more medication, long-acting beta agonists, and high-potency corticosteroids, to achieve asthma control comparable to those without a cat at home.
Learn why wearable remote monitoring of pulmonary function, oxygen saturation, and exercise challenge tests could close a critical gap in understanding COVID-19’s long-term impact on lung function.
See why the biggest barrier to home-based clinical monitoring is no longer device availability, but integrating multimodal biometric monitoring technologies into composite, fit-for-purpose digital measures.
See how biometric monitoring technologies in oncology have evolved from early activity tracking to today’s continuous monitoring approaches, and where the field is headed next.
Explore the EVIDENCE checklist, a multidisciplinary reporting standard designed to bring consistency and rigor to studies evaluating connected sensor technologies and digital measurement products.
Learn how applying the FDA’s biomarker qualification evidentiary criteria to remote cardiac safety monitoring could help sponsors detect cardiovascular liabilities earlier, before they become costly drug development attrition events.
Explore how two decades of laboratory biomarker validation experience is being applied to biometric monitoring technologies, offering a faster, more defensible path to fit-for-purpose digital biomarker qualification.
Learn why surface EMG, despite decades of research validation, still hasn’t become a routine tool in spinal cord injury rehabilitation, and what interdisciplinary steps could finally close that gap.
Explore why blood pressure is the only vital sign with internationally accepted validation protocols for biometric monitoring technologies, and what that validation gap means for trusting heart rate, respiratory rate, and oxygen saturation data collected at home.
Learn how at-home mobile spirometry achieved strong compliance and near-perfect agreement with clinic FEV1 measurements (r > 0.98) in a 12-patient asthma pilot study, while also boosting statistical power to detect treatment effects.
Explore the decision framework Koneksa Health developed for migrating clinical trial assessments from in-clinic to remote collection, weighing validity, safety, and regulatory implications rather than treating the shift as purely operational.
Discover how the V3 framework determines whether biometric monitoring technologies (BioMeTs) are fit-for-purpose to generate reliable digital biomarkers and endpoints in clinical trials.
Explore how Merck and Koneksa Health tested whether mobile health-derived heart rate and blood pressure data can match traditional clinic measures, and detect real pharmacological effects, in an 18-subject Phase I trial.
