Clario offers a cloud‑native platform that consolidates eCOA, cardiac, respiratory, imaging, and digital mobility endpoints with AI‑driven data cleaning, de‑identification, and real‑time quality monitoring for site, hybrid, and decentralized clinical trials. The solution provides regulatory‑compliant data capture, centralized analytics, and expert consulting to streamline operations, improve data integrity, and lower trial costs for biotech, CRO, and pharmaceutical sponsors.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical trials often suffer from fragmented data collection across multiple modalities, inconsistent endpoint quality, and regulatory compliance challenges, especially when studies span site‑based, hybrid, or decentralized formats. These issues increase operational complexity, delay decision‑making, and raise costs for sponsors seeking reliable efficacy, safety, and patient‑reported outcomes.
Solution
Clario delivers an integrated, cloud‑native endpoint technology platform that unifies validated software, connected devices, and AI‑driven analytics across eCOA, cardiac, respiratory, imaging, and digital mobility domains. The platform supports site, hybrid, and decentralized trials, enabling sponsors to capture high‑quality, regulatory‑compliant digital endpoint data at any location. Built‑in AI automates data cleaning, de‑identification, and real‑time quality monitoring, while a centralized analytics suite provides actionable insights and longitudinal reporting. Expert regulatory consulting and statistical services further reduce risk and accelerate study timelines. By consolidating all endpoint needs under a single partner, Clario streamlines operations, improves data integrity, and lowers overall trial costs.
Target Audience
Biotech firms, contract research organizations, and pharmaceutical sponsors conducting Phase I‑IV clinical trials, particularly those adopting hybrid or decentralized study designs.
Features
- Validated eCOA system with BYOD, web, and provisioned‑device options, supporting 120+ countries and 100+ languages.
- AI‑enhanced cardiac suite (continuous ECG, arrhythmia analysis, blood pressure monitoring, ICH E14 Phase I/TQT assessment) with patient‑friendly devices for site and remote use.
- Wearable Opal® sensor platform for objective precision‑motion endpoints, delivering high‑resolution mobility metrics and over 750 peer‑reviewed publications.
- Respiratory module offering site‑based spirometry, virtual home spirometry, cough & lung‑sound analysis, and DLCO assessment, all powered by AI interpretation.
- Medical imaging core‑lab services with multimodal capabilities (CT, MRI, endoscopy) and SMART Submit tool for automated DICOM de‑identification and 21 CFR Part 11/EU GDPR compliance.
- Trial enablement suite featuring eligibility workflow automation, source‑document management, BI reporting, and safety‑risk analytics.
- Dedicated regulatory consultation and statistical analysis expertise from key opinion leaders to navigate complex approval pathways.
- Secure, cloud‑based infrastructure with role‑based access controls, end‑to‑end encryption, and 24/7 global support.