Clinical Operations

 

Category:

Exhibitor: AMAREX TAIWAN, LLC

Booth No: N/A

 

Characteristic

 

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.

Services include:
1. Site Identification and Qualification
2. Site Training and Initiation
3. Communications with Site Staff
4. Patient Recruitment Assistance​
5. Regulatory Document Management
6. Site Data and Regulatory Compliancy Monitoring
7. Site Protocol Compliance Monitoring
8. Investigation Product Inventory Monitoring

 

Other Products

 

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  Clinical Site Feasibility

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  Medical Writing

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  Pharmacovigilance

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  Consulting Services

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  Risk Based Monitoring

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  Data Management

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  Project Management

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  Regulatory Affairs

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  Biostatistics

 

 

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