Consulting
In addition to providing comprehensive services for entire projects,
Amarex also provides a wide variety of services for individual project
elements. When you employ Amarex for any of these services, you
will profit from the same experience, commitment to excellence,
thoroughness, rapid turnaround, cost efficiency, innovation, and
leading edge technology we apply to all of our work.
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Advantages of AMAREX consulting:
• Successful industry, regulatory, clinical,
and academia experience
• Scientifically sound design, conduct, and analysis
• Commitment to excellence
• Thorough preparation, follow-through, and analysis
• Automated and standardized processes and procedures
• Parallel processing approach
• Rapid turnaround and cost efficiency
• Leading edge technology and innovative thinking
• Clinical Development plans
• Review of NDA/BLA/PMA and other regulatory submission
• Protocol development
• Standard Operating Procedures
• Experimental design
• Sample size, power calculation
• Independent statistician for DSMC
• Analysis plans, interim analyses
• Presentations to FDA, DSMC, ACM
• Audits
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