Clinical Trial Medical Monitoring
Highest Standards of Medical Oversight, Risk Management & Participant Care
At Lotus Clinical Research, participant safety is our top priority. Every study we conduct is supported by experienced, therapeutically aligned medical professionals who serve as dedicated Medical Monitors. Their expertise ensures the highest standards of medical oversight, risk management, and participant care throughout the trial.
“Grounded in scientific rigor, driven by responsibility, and committed to bringing new therapies to market, our medical team ensures patient safety while supporting the integrity of your study data.”
Alina Beaton, MD
Medical Monitor
Comprehensive Medical Oversight
Our Medical Monitors play a central role in safeguarding trial participants while supporting sponsors with expert guidance.
Ongoing Safety Monitoring
- Safety Data Review: Medical review of key safety data—including adverse events, labs, and other findings—to identify trends, safety concerns, and ensure appropriate medical coding.
- Serious Adverse Event (SAE) Review: Expert evaluation of SAE reports for completeness, medical logic of causality and expectedness assessment, and compliance with reporting requirement.
- Committee Participation: Serve on Safety Review Committees and Data Safety Monitoring Boards (DSMBs) to provide independent medical oversight.
Strategic Input
- Protocol & ICF Development: Provide medical insight during the creation of protocols and informed consent forms to ensure accuracy and participant protection.
- Eligibility Reviews: Evaluate medical histories, lab results, and other records to confirm participants meet inclusion and exclusion criteria.
Expert Guidance
- Medical Consultation: Provide 24/7 real-time support for study teams and sites on medical issues that arise during the trial, including answering protocol-related inquiries such as inclusion/exclusion criteria.
- Risk Mitigation: Recommend safety measures and strategies to proactively protect participants and trial integrity.
Commitment to
Safety & Quality
By leveraging the expertise of our Medical Monitors, Lotus ensures trials are conducted with uncompromising attention to participant well-being and regulatory standards. Sponsors gain confidence knowing their studies are guided by medical professionals who prioritize both ethical conduct and scientific excellence.