Our real-time, global medical monitoring services integrate study data, external evidence, and regulatory inputs to support early signal detection, compliant reporting, and inspection-ready oversight so you 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 28 years of industry experience in medical, safety, QA, regulatory, and training to her role to inform early phase trial design decisions, help achieve inspection readiness, and enhance governance rigor.
Chief Medical Officer
Don’t let fragmented systems and reactive processes obscure signals and increase compliance risk.
We unify workflows, governance, and expertise to support participant safety, trial integrity, and fewer compliance gaps with:
Our clear escalation pathways enable rapid action on emerging signals to protect participants, maintain trial integrity, and keep studies moving forward.
Our causality and expectedness assessment are thorough, and our governance and regional pathways are integrated, reducing delays and errors and supporting compliant, consistent global safety reporting.
Our ongoing aggregated analysis with defined review cadence and clear outputs gives you earlier identification of emerging risks and supports timely, informed decisions across the entire clinical development process.
With structured governance, clear charters, robust documentation trails, and strict confidentiality and unblinding controls, we support transparent decisions and consistent, compliant conduct in your trial.
Dr. Sharon Moore - Chief Medical Officer
Review-grade focuses on retrospective data review and compliance checks. Decision-grade monitoring is proactive and real-time, integrating data, medical judgment, and defined pathways to drive timely, documented decisions and actions.
Through continuous data review, predefined escalation pathways, and close collaboration with investigators and committees. This enables rapid evaluation of emerging signals and timely actions such as dose adjustments or protocol modifications.
We apply a harmonized global process that maps regional requirements into a single workflow, providing accurate clock tracking, consistent case handling, and compliant submissions across all regulatory jurisdictions. Our approach and experience position us a leader in executing cross-border trials.
We use standardized criteria, medically qualified review, and documented decision frameworks. Governance includes clear roles, consistency checks, and alignment with reference safety information to support defensible assessments.
We define and track region-specific clock start rules within a centralized system, delivering accurate timing, clear documentation, and alignment with each authority’s reporting expectations.
Through ongoing aggregated data reviews across studies and sources, supported by a defined analysis cadence, signal tracking, and escalation processes to identify and act on emerging risks early.
It defines data sources, review frequency, analytical methods, roles and responsibilities, signal thresholds, and documentation requirements, providing a structured, repeatable approach to safety evaluation.
By maintaining continuous safety surveillance, organized data outputs, and predefined timelines, enabling efficient compilation, medical review, and on-time submission of regulatory reports.
We manage committee setup, charters, meeting logistics, and documentation to deliver clear decision records, confidentiality controls, and complete audit trails for all oversight activities.
Through validated workflows, standardized data reconciliation processes, and centralized review environments that align and cross-check data sources to promote consistency, completeness, and reliability.