To ensure participant safety, data integrity, and trial success, our clinical monitoring team undergoes the same training and testing as investigators for efficacy assessments (EASI, IGA, PASI, SALT, etc.). This rigorous training enables clinical research associates (CRAs) to quickly identify potential risks and escalate them to skilled clinical trial managers, ensuring a deep understanding of the efficacy evaluations they monitor. Also, our clinical monitoring team follows an adaptive (risk-based) approach, which emphasizes on-site monitoring efforts informed by the review of identified critical data and processes, issues, and trends. As a niche CRO specialized in dermatology and rheumatology, our CRAs and central monitors are highly trained and experienced in these therapeutic areas.
Risk Assessment
We systematically evaluate critical data and process risks associated with the protocol.
Site Management
We develop a unified, cross-functional plan to monitor identified trial risks.
Continuous Analysis
We integrate emerging risks, iteratively adapt the monitoring plan, and improve oversight in real time.
On-Site Monitoring
We investigate and address emerging process-related risks and concerns that can only be performed on-site.
Remote Monitoring
We remotely investigate and address emerging process or data-related risks and concerns.
Central Monitoring
We aggregate and analyze data to identify risks and trends and provide direction to monitoring activities.