AIRO: Independent Oversight for Clinical Trial Integrity and Risk Mitigation in Neuroscience
Ensuring data integrity in neuroscience clinical trials is essential to achieving regulatory approval and scientific credibility. These trials often rely on subjective outcome measures, complex inclusion criteria, and long study durations, increasing the risk of data inconsistencies, rater variability, and inappropriate subject enrollment. Without independent oversight, these challenges can lead to compromised trial outcomes, regulatory delays, and costly failures.
AIRO (Artificial Intelligence for Risk Oversight) is an advanced AI/ML-driven platform providing independent oversight of clinical trial data integrity. Developed under the expertise of Dr. Nily Osman, a board-certified neurologist with over 20 years of experience in clinical trial operations, AIRO functions as an autonomous risk mitigation tool that seamlessly integrates into electronic data capture (EDC) systems. AIRO proactively identifies risks, detects rating errors, and minimizes variability, ensuring trials are conducted with the highest level of scientific rigor and regulatory compliance.
Key Features and Benefits:
1. Independent Data Oversight for Trial Integrity
AIRO operates as an unbiased, third-party quality control system, continuously assessing clinical trial data for errors, inconsistencies, and deviations from protocol. This ensures sponsors, CROs, and regulators have objective verification of data reliability and trial integrity.
2. Seamless EDC Integration for Risk Mitigation
AIRO integrates directly into EDC platforms, enhancing real-time monitoring capabilities. Automated data validation and risk flagging allow for immediate intervention to prevent protocol deviations, enrollment errors, and regulatory concerns before they compromise trial outcomes.
3. Rater Performance and Variability Detection
AIRO identifies rating errors, inconsistencies, and poor-quality ratings that could negatively impact a clinical trial. By detecting rater drift, scoring anomalies, and outliers, AIRO ensures that a few poor-performing raters do not compromise study results. The platform enables targeted retraining and intervention, improving rater reliability and data quality.
4. Site and Investigator Performance Monitoring
AIRO employs a proprietary NEURITE (Neuroscience Trial Evaluation Index) ranking system to evaluate site and investigator performance. This enables data-driven site selection and ongoing assessment of site compliance, ensuring trials are conducted at high-performing locations with proven expertise.
5. Subject Appropriateness and Inclusion Monitoring
AIRO evaluates enrollment data in real time to ensure subjects meet strict inclusion criteria. By detecting deviations early, it reduces the risk of inappropriate recruitment that can skew results, lead to unnecessary data exclusion, or trigger regulatory red flags.
6. Customizable Alerts, Reporting, and Audit Readiness
AIRO generates detailed, actionable reports and customizable alerts, ensuring sponsors and trial monitors are informed of critical risks and anomalies in real time. The platform also provides comprehensive audit trails to support regulatory submissions and ensure compliance with global standards.
Why AIRO?
AIRO offers an unparalleled level of independent oversight, ensuring that neuroscience clinical trials maintain the highest standards of data quality, regulatory compliance, and operational efficiency. By identifying poor-quality ratings and mitigating the impact of rater errors, AIRO protects trial integrity and improves data reliability. Integrated directly into an EDC system, AIRO acts as a proactive safeguard against trial risks, reducing inefficiencies, improving trial outcomes, and enhancing regulatory confidence.
Discover how AIRO can fortify the integrity of your clinical trials—contact Osman Clinical Pathways today.
Regulatory Strategy
Our Regulatory Strategy service ensures your clinical program meets global standards from the start. We guide you through FDA, EMA, and international regulatory processes, covering IND/CTA submissions, orphan drug status, fast-track approvals, and more. Our team helps prepare for agency interactions and advisory meetings, ensuring compliance and mitigating risks at every stage to streamline your path to approval.
Risk Mitigation
Our Risk Mitigation service at Osman Clinical Pathways is designed to anticipate and address potential challenges in clinical trials, helping you optimize outcomes while reducing costs. We proactively identify risks related to patient recruitment, protocol adherence, regulatory compliance, and data integrity. By implementing tailored monitoring plans, real-time data reviews, and contingency strategies, we minimize trial disruptions and costly delays. Our approach ensures that your trial stays on track, maintains high-quality data, and adheres to timelines, ultimately increasing the likelihood of success and saving you valuable resources.
Clinical Trial Strategy
Our Clinical Trial Strategy service provides a comprehensive, end-to-end approach to planning and executing your clinical trials. We collaborate with your team to design a tailored roadmap that aligns with your development goals, regulatory requirements, and target patient population. Our strategic planning includes optimizing study design, selecting appropriate endpoints, and ensuring operational efficiency throughout the trial. By focusing on data integrity, patient-centric trial protocols, and streamlined timelines, we help maximize the chances of clinical and regulatory success, while minimizing risks and costs. Our goal is to deliver a clear, actionable strategy that drives your clinical program forward with precision and confidence.