Our clinical research services include clinical operations, clinical site feasibility and risk-based monitoring.

Clinical Operations

Our clinical research associates (CRAs) offer therapeutic expertise and clinical research experience, reducing manual effort while ensuring accurate data collection. At Amarex, CRAs have thorough knowledge and understanding of each study's SOPs, receiving specialized protocol training for each study. All of our CRAs are trained in GCP and HIPPA practices.

CRAs are assigned to a specific study, effectively and efficiently communicating with sites and providing comprehensive support. Our CRAs ensure safety reporting, review SAE and AE reporting procedures, validate and verify data collected at the site, and are available to answer product and protocol questions. This proactive approach allows our team access to real-time data and information, facilitating our focus on the study’s primary object and the implementation of proven strategies for the success of our client’s study.

Services include:

• Monitoring plan creation
• Site identification and qualification
• Site training and initiation
• Clinical site monitoring and closeout
• Communication with site staff
• Patient recruitment assistance​
• Regulatory document management
• Site data and regulatory compliancy monitoring
• Site protocol compliance monitoring
• Adverse event follow-up
• Investigational product inventory monitoring
• Risk-based monitoring

Clinical Site Feasibility

Proper planning, along with choosing the appropriate clinical investigator, is key to conducting an informed and successful trial. We ensure an efficient study startup by performing a comprehensive feasibility assessment that lets us provide sponsors with a custom, site-specific enrollment strategy and site selection plan.

Services include:

• Identifying investigators
• Developing protocols and protocol quality review
• Identifying protocol design concerns
• Collecting clinical investigator feedback
• Creating customized feasibility questionnaires to assess site capability and availability
• Developing site selection criteria and qualifications
• Defining enrollment strategies
  • Establishing enrollment rate expectations
  • Tracking site-specific enrollment
  • Developing subject recruitment contingencies

Risk-Based Monitoring

Maintaining participant safety, site consistency and data quality are paramount to a successful clinical trial outcome. Amarex's philosophy and strategy is to work alongside regulators and within industry guidelines to successfully implement appropriate study designs in all phases of clinical research. We collaborate closely with sponsors to come up with resolutions resulting in the best study-specific monitoring strategy for their clinical trial.

Services include:

• Study phase and design
• Program and protocol design
• Clinical monitoring
• Medical monitoring
• Remote monitoring
• Data and analysis review
• Primary and secondary study objectives
• Safety profile of product / device
• Complexity of study-specific requirements
• Study duration
• Site management
• Critical study data and processes identification
• Risk assessment to identify risks to critical data and processes
• Monitoring plan design tailored to identify important risk