28 June 2017
FDA Accepts Marketing Application for Review from Amarex Clinical Research on a Rescue ICU-Related Trial
Germantown, MD, USA – Amarex Clinical Research is working with a late stage company on a treatment for patients with an ICU-related indication. Amarex took over managing the entire trial services; regulatory, medical monitoring, patient recruitment, site finding and data management from another CRO that was experiencing difficulty in enrolling subjects into the trial. Amarex prepared and submitted the application to the FDA.
This trial was challenging to enroll, as patients were presenting in a critical care setting. The trial came to Amarex after two years with minimal enrollment. In that first year, Amarex exceeded the enrollment of the past two years combined, and then averaged more than triple the enrollment in the years afterwards getting the trial back on track and completing the enrollment.
“We are very gratified to hear that the FDA has accepted this application for review” said Amarex’s CEO, Kazem Kazempour, PhD. “This trial was a real challenge, and we at Amarex are very proud of the creativity and drive that was utilized to solve the enrollment problems inherent with this study. We look forward to working with our client to see this application through to approval.”
About Amarex Clinical Research, LLC
Amarex is a global full service Contract Research Organization (CRO), whose leadership team has over 60 years of conducting biomedical research, and has been involved in executing over 400 clinical research projects in over 35 countries. Their knowledge and experience in conducting comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications Submissions, Compliance Audits, Clinical Operations, Adaptive Study Designs, Biometrics, Statistical Analysis, Data Management and General Consulting has enabled Amarex to take its clients through the entire process from initial product concept to FDA approval. Amarex’s goal is to help its clients bring their products to the market as quickly and efficiently as possible.
20201 Century Blvd, 4th Floor
Germantown, MD 20874