Consulting Services

 

Category:

Exhibitor: AMAREX TAIWAN, LLC

Booth No: M728

 

Characteristic

 

Amarex believes in a data-driven and collaborative approach, while striving to provide accurate regulatory information and outstanding research guidance. Our leadership team has over 30 years of experience in conducting clinical trials and has been involved in over 400 clinical studies in more than 35 countries. Currently, we are conducting studies in the United States, Canada, Europe and through partners in Asia. We have conducted GCP and GMP compliance audits in Europe, South America, Israel, China, Taiwan, Korea and the United States.
Our services include:
1. Clinical Development Plan
2. Product Development Plan
3. Two Clinical Data Collection Options (e.g. EDC or paper-CRF)
4. Statistical Support : Power Calculation​ | Randomization | Statistical Methodologies | Programming | Interim Analysis
5. Clinical Study Design: Endpoints, Adaptive & Enrichment Clinical Trials, Rescue Trials
6. Medical Writing and Clinical Research Results Evaluation
7. Operational Support for Development Projects
8. Patient Recruitment
9. Non-Clinical Development (Small Molecules, Biologics and Medical Devices)
10. Investigator & Sponsorship Partnerships
11. Network of Regulatory Agency Consultants
12. Data Safety Monitoring Board Meetings
13. Advisory Committee Meetings
14. Safety and Phamaracovigilance
15. Regulatory Strategy Planning
16. Due Diligence Assessments and Compliance Strategies
17. FDA Application Submission (US and International)

 

Other Products

 

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  Medical Writing

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  Biostatistics

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  Clinical Site Feasibility

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  Clinical Operations

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  Regulatory Affairs

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  Data Management

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  Project Management

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  Pharmacovigilance

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  Risk Based Monitoring

 

 

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