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CLINICAL OPERATIONS

ACHIEVEMENT

Amarex's CRAs offer therapeutic expertise and clinical research experience reducing manual effort while providing high quality analyzed data. Our CRAs have thorough knowledge and understanding of each study's SOPs and have received specific protocol training for those individual studies.

CRAs are assigned to a specific study and effectively and efficiently communicate and provide comprehensive support with the site to ensure safety monitoring, review SAE  and AE reporting procedures, validate and verify data collected at the site, conduct a medical review of trial related documents and support to answer product and protocol questions.

Using this proactive approach provides our team the ability to use real-time information, in order to focus on the study's primary objective, and to implement proven strategies for the success of our client's study.

Services include:

  • Site Identification and Qualification

  • Site Training and Initiation

  • Communications with Site Staff

  • Patient Recruitment Assistance​

  • Regulatory Document Management

  • Site Data and Regulatory Compliancy Monitoring

  • Site Protocol Compliance Monitoring

  • Investigation Product Inventory Monitoring

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