CONSULTING SERVICES

PARTNERSHIP

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 70 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.

We are committed to achieving the best possible outcome at each step of the process leading up to product approval. We have the experience and knowledge to provide the most comprehensive operational and logistical tools, technically advanced services, and forward-thinking solutions that take our client's medical products through the entire process from the initial product concept to FDA approval.

Amarex Clinical Research is a valuable partner that is committed to our client’s success...

​Our services include:

  • Clinical Development Plan

  • Product Development Plan

  • Two Clinical Data Collection Options (e.g. EDC or paper-CRF)

  • Statistical Support 

    • Power Calculation​ | Randomization | Statistical Methodologies | Programming | Interim Analysis

  • Clinical Study Design

    • ​Endpoints​

    • Adaptive & Enrichment Clinical Trials​

    • Rescue Trials

  • Medical Writing and Clinical Research Results Evaluation

  • Operational Support for Development Projects

  • Patient Recruitment

  • Non-Clinical Development (Small Molecules, Biologics and Medical Devices)

  • Investigator & Sponsorship Partnerships

  • Network of Regulatory Agency Consultants

  • Data Safety Monitoring Board Meetings

  • Advisory Committee Meetings

  • Safety and Phamaracovigilance

  • Regulatory Strategy Planning

  • Due Diligence Assessments and Compliance Strategies

  • Regulatory Application Submissions (US and International)

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           © 2019 Amarex Clinical Research, LLC. All rights reserved.                                                                                                                                                                                                                                                   Top of Page 

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