Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications.
Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost-efficient services. For more information visit www.amarexus.com.
We offer accelerated COVID-19 product authorization and approval services. These services include preparation and submission of emergency and compassionate use INDs, IDEs, EUAs, and CTAs to the US FDA and EMA on behalf of companies that have medical products with potential application for the treatment, diagnosis, or prevention of COVID-19. We can also assist clients with obtaining rapid FDA approval for masks and other personal protective equipment (PPE) intended for use by healthcare professionals.
Connect with us at the Bio Innovation Virtual Conference held on October 5-6, 2020. More information is available at https://www.marylandlifesciences.com/conference/".