Amarex Completes 505(b)(2) Product Trial in Six Months
Germantown, MD, USA (September 10, 2015) – Amarex recently completed a successful PIV trial for a 505(b)(2) cardiovascular product within six months of initiating trial setup activities, including completion of the statistical analysis and first draft of the clinical study report. Amarex provided full trial services: site contracting and management, monitoring, data management, statistical analysis, and report writing.
According to Dr. Tina Motallebzadeh, study Project Manager at Amarex, "We were very pleased to have the opportunity to conduct this trial to support the expanded use of the product. Amarex's expertise in parallel processing of trial services was the main factor enabling the rapid setup and completion of this trial. We have seen that this approach also can improve the likelihood of favorable trial outcomes."
About Amarex Clinical Research
Amarex 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 Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
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