Our strategic trial design, risk-based quality management (RBQM), and centralized monitoring deliver high-quality trial data, protect timelines, and enable confident decisions, so your early phase clinical development can move at the speed of science.
As Chief Medical Officer, Dr. Sharon Moore is responsible for strategic development and medical oversight of the clinical studies, and oversees the medical affairs, pharmacovigilance, strategic regulatory, and medical writing teams. She brings nearly 30 years of industry experience in medical, safety, QA, regulatory, and training to her role to inform early phase trial design decisions and help sponsors balance dose optimization with patient-centric considerations
Chief Medical Officer
No matter if you’re running complex designs, such as basket trials and combination regimens, our continuous risk management, hybrid monitoring approaches, and strong data governance allow us to:
Our proactive approach integrates risk management throughout your trial life cycle to safeguard data integrity, protocol compliance, and manage patient safety while accelerating timelines and reducing costs.
We deliver the additional vigilance that early phase trials require through central monitoring, reducing the time and cost to reach critical decision points.
We apply a unified, strategic approach to manage complex clinical activities and adapt to changing study needs, enhancing data quality and accelerating timelines while promoting regulatory compliance.
We bring agility to fast-evolving programs, enabling strategy pivots, interim analysis-driven expansions, and seamless continuity through transitions.
Sharon Moore, M.D., MBA, MPH - Chief Medical Officer
Whether you come to us for full service, end-to-end support, or on a single project basis, we optimize your early phase development with:
When you partner with Caidya, you’ll set a new standard for early phase efficiencies.
Our comprehensive, risk-aware strategy and strong collaboration promote timely execution, maintain compliance and participant safety, and enable faster regulatory submissions.
Partner with us for access to:
Early phase trials involve limited patient numbers, first-in-human exposure, and evolving protocols, increasing uncertainty. Rapid decisions and incomplete data heighten the need for vigilant safety monitoring and high-quality, reliable data.
Centralized monitoring is an off-site, centralized review of aggregate data against predefined quality thresholds, using real-time analytics to identify trends, outliers, and risks across sites. Onsite monitoring focuses on in-person review for direct access to source data and EMR that cannot be viewed remotely. Onsite monitoring can also support pharmacy accountability by verifying control of IMP, laboratory sample collection, shipment, and storage, medical record review, and facility assessment. Together in a hybrid model, they provide broader and deeper oversight.
CtQ factors are identified during protocol design by focusing on elements essential to patient safety and data integrity. They are continuously monitored and refined throughout the study using risk-based approaches.
Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) are predefined metrics that track study risk and quality. When thresholds are exceeded, they trigger targeted investigation and corrective actions.
Risk-Based Quality Management (RBQM) focuses on high-risk data and processes rather than 100% Source Data Verification (SDV), using centralized monitoring and analytics to maintain quality while reducing unnecessary site burden.
We design flexible dose escalation and expansion strategies, incorporate real-time safety and PK/PD data, and support data-driven decisions to identify optimal dosing before advancing to later phases.
We apply integrated operational and data strategies to manage multiple cohorts, indications, and adaptations, ensuring consistency, scalability, and clear oversight across complex trial structures.
We use targeted site selection, streamlined start-up processes, and proactive patient identification strategies to quickly activate sites and efficiently enroll the right patients.
We standardize data formats, implement governance frameworks, and optimize reconciliation workflows to reduce discrepancies, streamline data flow, and improve overall data quality.
Every Caidya full-service trial has a dedicated Central Risk Manager who oversees risk assessment from protocol review through database lock, monitors Critical to Quality (CtQ) factors to prevent meaningful errors, and ensures real-time adaptation to emerging risks, delivering continuous quality oversight.