Caidya & Simbec-Orion announce strategic combination. Learn More
Our risk-based quality management (RBQM) services proactively adapt at the speed of science to safeguard data integrity, inspection readiness, and patient safety at every step.
With over 20 years of experience in clinical research, Sarah Gill leads strategic initiatives to optimize trial quality, efficiency, and oversight at Caidya. Drawing on a deep background in monitoring, Sarah brings a rare combination of operational insight and strategic foresight to modernize RBQM implementation across global programs. Sarah has mentored professionals across functions, fostering a culture of collaboration, innovation, and continuous improvement, and is a committed advocate for risk-based and data-driven approaches that empower teams and drive smarter, safer, and more efficient clinical trials.
Executive Director, Clinical Monitoring
Our end-to-end RBQM model delivers TMF-ready documentation, traceable decisions, and efficient risk-based monitoring — every time.
From pre-award CtQ risk review and protocol design to ongoing monitoring and database lock close-out, you get:
We align with FDA, EMA, and NMPA expectations and bridge regional differences to deliver consistent, defensible risk management and audit-readiness worldwide.
We identify CtQ factors and implement balanced ranges to clearly distinguish trial-level and site-level signals, so you can make the right decisions faster.
We identify CtQ factors and implement balanced ranges to clearly distinguish trial-level and site-level signals, so you can make the right decisions faster.
We provide clear role definition, escalation pathways, and centralized coordination, so you get complete accountability and reduced fragmentation across vendors.
Sarah Gill - Executive Director, Clinical Monitoring
With experience helping nearly 280 trials stay ahead of potential issues and unmatched expertise in preventing CtQ errors and integrating risk management, we deliver:
We create a unified RBQM framework built on consistent principles, documentation standards, and governance, then map regional expectations (e.g., FDA, EMA, NMPA) into a single traceable approach. The goal is to create a defensible model with documented rationale that can be interpreted consistently across inspections.
CtQs should be derived directly from protocol objectives, patient safety risks, and data integrity needs. The key is prioritization: focus on what could materially impact trial outcomes and avoid expanding into excessive metrics that create noise rather than clarity.
QTLs are study-level indicators tied to trial endpoints, while KRIs are typically site- or process-level signals used for monitoring performance and risk trends. Thresholds are set using historical data, protocol context, and risk tolerance, then refined as the study progresses.
By shifting to a risk-based approach that combines targeted SDV/SDR, centralized monitoring, and analytics. This enables verification to focus on high-impact data while maintaining compliance through documented rationale and traceable risk decisions. Regulators do not expect 100% SDV/SDR, they require that SDV and SDR are targeted to the most critical areas only.
In early phase, centralized monitoring emphasizes close safety vigilance, rapid signal detection, and intensive data review. In later phases, it becomes more trend-focused, scaling across sites and geographies to detect systemic issues and performance variability.
You standardize data flows into a unified review environment, apply analytics to harmonize disparate sources, and use cross-dataset signal detection to identify inconsistencies, trends, and anomalies across the full data ecosystem.
Through clear governance structures, defined roles and escalation pathways, and centralized tracking of risk and performance. Sponsors retain accountability, while CROs provide structured reporting, transparency, and coordinated execution across vendors.
Inspectors expect a clear RBQM plan, documented CtQ rationale, defined QTL/KRI thresholds, risk review logs, action tracking, and evidence of ongoing decision-making, ideally all traceable in TMF-ready formats.
The RBQM plan should be a living document updated at key milestones such as study start, enrollment shifts, emerging risk identification, protocol amendments, and during periodic risk review cycles.
Breaches are assessed for clinical and operational impact, then categorized by severity. This approach drives defined actions, ranging from monitoring adjustments to formal escalation, supported by documented rationale and governance review.