Frequently Asked Questions

What does Amarex do?

Amarex, an NSF company, is a Clinical Research Organization (CRO) that supports the entire lifecycle of clinical trials from planning to regulatory submission. We provide expert regulatory and clinical trial services to clients in the pharmaceutical, biotechnology, medical device and diagnostic industries.

What services does Amarex offer?

Amarex offers a wide range of supporting the regulatory and clinical trial services spaces. Our regulatory services include strategy, FDA meetings and FDA applications; while our clinical work encompasses project management, data management, biostatistics, medical safety, medical writing, and more to support pharmaceutical, biotechnology, medical device and diagnostic companies.

Which therapeutic areas does Amarex specialize in?

Amarex has expertise in all therapeutic areas, including: oncology, wound healing, neurology, cardiology, infectious diseases, immunology, rare diseases, and more. Amarex’s multi-disciplinary approach supports diverse clinical research needs.

How can Amarex help with regulatory submissions?

Amarex assists clients with the creation of regulatory approval strategies, preparing regulatory approval applications, and communications and meetings with regulatory authorities such as the FDA and EMA to ensure compliance and expedite approval processes.

What is the process of starting a clinical trial with Amarex?

To start a clinical trial with Amarex, clients typically begin with a consultation to discuss their specific needs and objectives. Amarex then develops a customized project plan, including timelines, budget, and milestones. The team coordinates all aspects of the trial, from protocol development and site selection to data management, analysis and final study reporting writing.

What makes Amarex different from other CROs?

Amarex stands out due to its personalized -collaborative approach, extensive expertise, and commitment to quality. Their experienced team provides tailored solutions to meet the unique needs of each client, ensuring efficient and successful clinical trial outcomes.

How does Amarex ensure the quality of its clinical trials?

Amarex ensures the quality of its clinical trials through rigorous adherence to Good Clinical Practice (GCP) guidelines, comprehensive quality assurance programs, and continuous training of staff. We implement robust monitoring and auditing procedures to maintain high standards throughout the trial process. Amarex has been successfully audited by the U.S. FDA and Taiwan FDA.

Can Amarex handle global clinical trials?

Yes, Amarex has managed global clinical trials across the United States and Asia. We have experience working with international regulatory bodies, coordinating multi-center trials, and navigating the complexities of conducting research across different countries and regions.

What kind of clients does Amarex work with?

Amarex works with a diverse range of clients from pharmaceutical companies and biotechnology firms to medical device and diagnostic manufacturers. Amarex services organizations of all sizes, from startups to established industry leaders.

Where can I find more information about Amarex’s services?

More information about Amarex’s services can be found on our website, Amarex CRO. Here you’ll find detailed descriptions of our services, case studies, and contact information.