Save future data, with AI-enabled Risk Based Monitoring
When performing spirometry, there is a significant variation in expertise and experience between the different study sites. ArtiQ.RBM detects sites that could benefit from a retraining, and automatically proposes specific spirometry aspects to focus on. Furthermore, ArtiQ.RBM checks for potential data fraud and suggests prioritized action points to take
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 & potential data fraud.
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!