Make timely and informed decisions on spirometry quality. Unleash the potential of spirometry AI to deliver reliable outcomes.

Risk Based Monitoring is an important tool to optimize the efficiency in clinical research. It allows to focus your energy & resources on data sources (sites, participants, …) that require a closer follow-up, and provides insights in spirometry data quality patterns & AI-based data integrity check.

ArtiQ.RBM provides actionable Risk Based Monitoring reports, guiding you towards preventive and/or corrective actions specifically for spirometry. It can be applied to your clinical study based on the context & requirements. Contact us to find out more!

Risk Based Monitoring (RBM) is an important tool to optimize efficiency and data quality in clinical trials, but what do regulatory bodies think about RBM? In the FDA’s final ‘Guidance for the industry’ document on Risk-Based monitoring, it says: “Sponsors (…) are required to provide oversight, including ensuring proper monitoring of the investigation. Such oversight helps to ensure (…) and the integrity of the data submitted to the FDA.

Therefore, sponsors should implement a system to manage, (…), both risks to participants (e.g., a safety problem) and to data integrity (e.g., incomplete and/or inaccurate data). This system should include a risk-based approach to monitoring tailored to the potential risks for the specific clinical investigation. Effective implementation of risk-based monitoring, (…), should help maximize the quality of a clinical investigation.”

How can I use ArtiQ.RBM?

I have a new study and I want to have regular ArtiQ.RBM reports during my study…

ArtiQ.QC will be over-reading your spirometry data in real-time. Additionally, ArtiQ will deliver ArtiQ.RBM reports based on a frequency that fits your context: bi-weekly, monthly, every 3 months…

I have data from an ongoing / closed study, and I want to retrospectively check which sites needed more support, a detailed site review, …

ArtiQ can retrospectively check your data with ArtiQ.QC and create a retrospective ArtiQ.RBM report. Contact us to find out how we can collaborate!




We have partnered with ArtiQ on multiple projects across obstructive and restrictive lung diseases. Their ArtiQ.QC product enables Koneksa and our sponsor partners to have confidence in the data that is being collected and enables real-time evaluation to ensure that patients are contributing high-quality pulmonary function tests remotely. This data, paired with ArtiQ’s RBM reports enables both patient-level and site-level intervention.

Matthew Cantor

Co-Founder, Koneksa

Digital health solutions and artificial intelligence are becoming key to optimising clinical trial design and delivery. The real-time feedback on spirometry that our partnership with ArtiQ brings, as well as their AI-enabled Risk Based Monitoring, helps AstraZeneca to increase the reliability of our data, allowing us to improve patient care and drive healthcare transformation.

Rod Hughes

Executive Medical Director, Early Respiratory and Immunology, AstraZeneca

Request more ArtiQ.RBM info

Do you plan a project or study where spirometry is used? Request more information about ArtiQ.RBM and ArtiQ.QC!

    Certification & Standards
    ArtiQ.QC is developed taking into account latest guidelines and standards. ArtiQ is an ISO 13485 certified company.