Amarex Clinical Research
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| | |
| Amarex Clinical Research, LLC | |
|---|---|
| Type | Private |
| Industry | Biotechnology |
| Founded | 1998 |
| Headquarters | Germantown, MD |
| Number of employees | 51-200 |
Contents
History
In 1998, Amarex Clinical Research was established as a Global Full Service CRO. We are collaborative partners with our clients, while providing comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Application Submissions, Compliance Audits, Adaptive Study Designs, Statistical Analysis, and General Consulting. We are in the business of helping our clients from beginning to end with the final result being a successful development program leading to FDA approval of our clients medical products.
Amarex believes in a data-driven and collaborative approach. As we work closely with our clients, we strive to provide accurate regulatory information and outstanding research guidance. Our knowledge, expertise, and experience with products and indications allow us the opportunity to provide tailored solutions to our clients. 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 advance services, and forward-thinking solutions to take our client through the entire process from the initial product concept to FDA approval.
Our leadership team has been involved in executing over 300 clinical research projects in over 35 countries. Our experts have over 60 years of combined experience and expertise in conducting biomedical research, standardization of data management protocols, oversight of clinical trial operations, and trial management of Phase I through IV studies of drugs, devices, and biologics, along with creating and implementing regulatory procedures on both a domestic and international scale. This truly is, where experiences is the difference. [1]
Amarex Clinical Research to Attend BIO Europe in Berlin
Germantown, MD, USA - Amarex will be attending the BIO Europe conference in Berlin over November 6-8. In order to further expand both its clinical trial services in Europe, and its customer base in Europe, Amarex will be attending this conference for the first time. Members from both the Amarex US and Amarex Europe teams will be present. They will be meeting with current and potential clients during the event. Amarex conducts clinical trials in Europe for clients across the globe, and also helps clients in Europe bring their products to the US.
Dr. Kazem Kazempour, President and CEO of Amarex, said: “We look forward to having staff attend this conference. Our presence there is a sign of Amarex’s increasing work in Europe, and our growing client base there. We are excited to continue our growth in Europe through the meetings that will take place at this event.” If you are interested in meeting with representatives from Amarex at the conference regarding your project, please contact Amarex at the email provided below. 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.
Services
- Project Management
- Clinical Site Feasibility
- Clinical Monitoring
- Data Management
- Medical Affairs
- Pharmacovigilance
- Biostatistics
- Regulatory Affairs
- Quality Assurance
- Consultancy
Experience
In terms of experience, Amarex states that they provide unparalleled and unmatched value to clients on a full service scale. They manage all aspects of the study implementation; from feasibility and site selection to clinical monitoring and data management, on the FDA approval and post approval studies. Amarex understands that effective and accurate handling of information during a clinical study is what drives a successful trial. [2]
Amarex has experience in the following therapeutic areas (Phase I-IV):
- Addiction
- Anti-Viral
- Cardiovascular
- Central Nervous System (CNS)
- Dermatology
- Diabetes
- Endocrinology
- Gastroenterology
- Genetic Diseases
- Hematology
- HIV
- Immunology
- Infectious Diseases
- Medical Devices
- Neurology
- Oncology
- Orphan Indicationsy
- Pain Management
- Pediatric Studies
- Respiratory Medicine
- Rheumatology
- Urology
- Vaccines
- Wound Healing
Pharmacovigilance
Amarex states that their highly experienced clinical research physicians provide medical expertise to evaluate the safety and conduct of a clinical trial. Their support safeguards the success of a clinical trial through delivery of high quality clinical data to our customers.
They provide the following services [3]:
- 24-Hours/7-Days Serious Adverse Event (SAE) reporting and medical coverage
- Preparation of narratives, Medwatch and CIOMS reports
- Review of potential subject eligibility
- Medical review of adverse events, labs, vital sign, ECG's, and any other study related datasets
- Answer investigational product/protocol related questions
- Review of Case Report Form design
- Medical support to clinical sites, clinical research associates, clinical data managers and project teams
- Coding of adverse events, concomitant medications and other study related data
- Medical review of all clinical trial related documents i.e. clinical study reports, etc
- ↑ https://www.amarexcro.com/advantages.html
- ↑ https://www.amarexcro.com/experience.html
- ↑ https://www.amarexcro.com/pv.html
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