Ensuring subject/patient safety and compliance with a clinical trial protocol’s requirements are paramount to any study’s success in meeting its intended objectives.

Medical monitors must have the clinical and research expertise required to provide medical oversight throughout the design, execution, and reporting of clinical trials. Our experienced Medical Monitors are available to provide strategic drug development guidance and review key study documents and safety information acting as a lead medical resource to support investigators and sites.

Perhaps CRO has medical monitoring bandwidth issues. Whatever the reasons, your study will experience delays without an experienced and dedicated sponsor medical monitor. Our dedicated sponsor medical monitor plays an essential role in sites’ participation and patient enrollment, representing you, the sponsor, and communicating your commitment to the ongoing study.

In addition, our dedicated sponsor medical monitors take responsibility for critical functions such as:

• Inclusion/Exclusion criteria issues
• Protocol exemptions and deviations
• A medical emergency involving patient safety
• Medication issues
• Laboratory findings
• Reporting a serious adverse event (SAE)
• Causality assessment discussions