RISK-BASED MONITORING

RESOLUTION

Maintaining participant safety, site consistency and data quality are some of the most important responsibilities of clinical trials. 

Amarex's philosophy and strategy work alongside with the regulatory and industry guidelines and have lead to successful implementation in a variety of study designs and phases.

Our collaborative approach allows Amarex and our clients to come up with resolutions that are 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 & Analysis Review

  • Primary and Secondary Study Objectives

  • Safety Profile of Product / Device

  • Complexity of Study-Specific Requirements

  • Study Duration

  • Site Management

  • Identify Critical Study Data and Processes

  • Perform a Risk Assessment to Identify Risks to Critical Data and Processes

  • Design a Monitoring Plan Tailored to Identify Important Risk

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