TFDA Approves IND Application for an Amarex Client Treating Pancreatic Cancer
Germantown, MD, USA (February 11, 2020) – Amarex Clinical Research, LLC announces that the Taiwan Food and Drug Administration (TFDA) approved an IND application for an Amarex client to proceed with their Phase I/IIa study of a new chemical entity (NCE) in the treatment of patients with pancreatic cancer. Pancreatic cancer is a deadly cancer with a high unmet medical need and preliminary nonclinical data shows potential efficacy and safety of the new chemical entity in the treatment of pancreatic cancer.
Amarex Taiwan’s regulatory department submitted the IND application for this study to the TFDA on behalf of the study sponsor. With strong effort, prudent revision, and hard work, this IND application accepted by TFDA 10 days before the deadline of review calendar without any amendment, implying the high quality and reliability of Amarex Taiwan’s team. Amarex’s clinical, biometrics, and regulatory department is expected to further manage, monitor, and work on the data analysis of this study. President & CEO of Amarex, Dr. Kazem Kazempour stated that, “We look forward to working closely with our client on this project. We expect that we will be able to move quickly into the next phase of the trial, and we anticipate bringing a novel oncology product to market.”
About Amarex Clinical Research, LLC, an NSF International company
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 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.
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