Services by CompanyAmarex Clinical Research

Amarex Clinical Research, an NSF International Company, is a full-service, international Clinical Research Organization (CRO). It has extensive experience successfully performing clinical studies across all phases of research and discovery, development, validation and approval. Based in Germantown, MD, the offices are within easy reach of the National Institute of Health (NIH) and the Food & Drug Administration (FDA).

Services include product development plan creation, study feasibility, project management (Phase I-IV, BE/BA, PK/PD), protocol writing, site selection and management, data management (EDC or paper CRF), clinical monitoring, safety and pharmacovigilance, biostatistics, medical writing, clinical study report writing, regulatory affairs, FDA applications (IND, IDE, 510(k), NDI, NDA/505(b)(2), ANDA, BLA, PMA), U.S. agent to FDA for correspondence, meetings, presentations, negotiations, data safety monitoring committee and clinical ethics committee management, auditing for FDA and ICH compliance (GLP, GCP, GMP, GAP), training seminars and consulting: regulatory strategy, statistics, study design, CMC, etc.

Amarex Clinical Research is an expert CRO, expediting patient access to safe and effective clinical products.

For more information, please visit the Amarex website.

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