Medical Device
Certified under EU MDR 2017/745, bearing the CE mark
By integrating continuous data collection directly into routine patient care, Boli Care powers longitudinal follow-up, regulatory-grade real-world evidence, and future clinical research initiatives across obesity and cardiometabolic health.
Co-developed with endocrinologists, nutritionists, dietitians, and patient advocates, Boli Care aligns with national and international health guidelines for seamless integration into clinical workflows.
Patient-Reported Outcomes (PROs) and digital medical devices have revolutionized clinical impact and workflow efficiency across other chronic conditions. Why not in obesity?
We are establishing a standardized PRO framework aligned with ICHOM recommendations. This empowers next-generation longitudinal monitoring, tracking psychological well-being, eating behaviors, physical activity, and pharmacological tolerance to enhance scientific understanding and patient outcomes.
Clinical investigator, life science RWE team, HTA agency, or patient advocacy organization: we welcome conversations regarding collaborative research. Detailed study protocols and roadmaps shared under NDA.
Designed for academic researchers, principal investigators, and RWE teams, Boli Care combines real-world data capture, regulatory compliance (MDR, GDPR, GCP), and healthcare IT interoperability.
Continuous, structured patient signal capture between consultations: longitudinal tracking of AOM tolerance, lifestyle adaptations, and treatment persistence.
Clinical command center for researchers and clinicians: longitudinal cohort tracking, real-time pharmacovigilance, and structured data exports.
Analytics engine integrating continuous PRO streams, nutritional patterns, and behavioral drivers to characterize individual response trajectories.
Strict regulatory compliance: Class I Medical Device (EU MDR 2017/745), GDPR compliance, GCP audit trails, and certified health data hosting (HDS).
Boli Care conducts its own multi-year clinical research roadmap, designed, funded, and managed internally—from early scientific commentaries to pivotal randomized trials and health economic evaluations.
Overview of our internal studies, designed, funded, and conducted by Boli Care. Protocols, outcome measures, and timelines shared under NDA.
| ID | Type | Phase | Status | Details |
|---|---|---|---|---|
| BOLI-001 | Scientific Commentary / Perspective (Lancet DH) | Phase 1 | Ready to submit | On request |
| BOLI-002 | International Community Survey | Phase 1 | In design | On request |
| BOLI-003 | Prospective Digital In-App Cohort | Phase 2 | In preparation | On request |
| BOLI-004 | Scoping Review & Meta-Analysis (PRISMA-ScR) | Phase 1 | In preparation | On request |
| BOLI-005 | Pivotal Randomized Controlled Trial (Pivotal RCT) | Phase 3 | In preparation | On request |
| BOLI-006 | Structured RWD Generation System (PECAN / DiGA) | Phase 4 | Planned | On request |
| BOLI-007 | Final Meta-Analysis & Health Economic Evaluation | Phase 5 | Planned | On request |
This represents our internal research agenda; sample sizes, clinical sites, and timelines remain confidential. Email us at research@boli.care to receive our detailed briefing, explore co-publication opportunities, or establish an HTA collaboration.
Boli Care is deployed progressively with healthcare professionals. Share your contact information to schedule a tailored presentation of our platform and investigator dashboard.
Thank you for your interest. A member of our clinical team will contact you within 48 hours to schedule a demonstration of Boli Care.
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