Complete clinical trial quality assurance (QA) is just how Caidya does things. From early clinical development through submission, we keep you compliant and confident as you move at the speed of science.
As Senior Vice President, global quality services, Marie Hanley oversees quality and regulatory compliance activities at Caidya. Marie has worked in the clinical research industry for more than 30 years and brings expertise in audits, compliance and process improvement, and global regulatory inspection to her role. Prior to Caidya, Marie spent 17 years in global regulatory and quality assurance roles and began her career as a research nurse and study coordinator.
Senior Vice President, Global Quality Services
From data and safety to compliance and execution, our QA services are second to none. We proactively manage protocol risks and reduce deviations from design to execution, so you get:
Our structured dashboards and review routines enable proactive issue detection and drive continuous control, compliance, and data confidence.
From structured assessments and complete documentation to training evidence and disciplined CAPA management, we train teams and implement processes that support confident regulatory
Our systematized oversight, aligned training, clear communication pathways, and proactive site support reduce variability and provide uniform quality execution across all study stakeholders.
With deep root cause analysis, effectiveness checks, and trend monitoring, our CAPA management checks that issues are not just resolved but also prevented from recurring.
Marie Hanley - Senior Vice President, Global Quality Services
If you want proactive risk management, precision-driven patient recruitment, global execution excellence, and high-quality, audit-ready data, use our comprehensive QA services:
When you partner with Caidya, you’ll get scalable QA oversight and better global quality from Phase I onward, thanks to our experience from 73 site audits spanning Phases I-IV and 21 countries across 900+ sites — in the last five years alone.
We embed QA from study design through start-up by establishing early risk identification, defining quality plans, and setting governance frameworks. This enables proactive monitoring and controls that prevent issues rather than reacting to them later in the study lifecycle.
Our RBQM approach uses structured risk assessments, predefined triggers and thresholds, and a defined oversight cadence. This is supported by clear documentation and governance routines that enable continuous, proactive quality oversight.
We maintain continuous inspection readiness through structured assessments, documentation discipline, and readiness checks tailored to regional expectations across FDA, EMA, NMPA, and other regulators, helping sponsors become audit-ready.
We manage quality through strong vendor oversight, reconciliation checkpoints, and end-to-end audit trails that ensure consistency across fragmented systems, reducing variability and strengthening data integrity across all study partners.
QA promotes compliance and timeliness across safety and PV processes through structured oversight, escalation pathways, and interface checks, reducing delays and ensuring aligned execution across safety and clinical operations.
We reduce variability through standardized processes, consistent training, and feedback loops from monitoring and audits, driving improved site performance and minimizing protocol deviations across global studies.
Our CAPA approach emphasizes rigorous root cause analysis, effectiveness checks, and trend monitoring to ensure issues are not only resolved but also prevented from recurring across studies and systems.
We support global complexity through structured governance models, controlled documentation processes, and regional alignment frameworks that ensure consistent quality across evolving multi-country study footprints.
Yes, we support decentralized, data-intensive trials by overseeing multiple data streams, qualifying vendors, and enabling real-time quality review to ensure consistency across digital and hybrid trial models.
Sponsors can expect structured quality plans, defined audit schedules, readiness checkpoints, governance cadence, and ongoing quality reporting throughout start-up and conduct to ensure sustained compliance and inspection readiness.