It has extensive experience successfully performing clinical studies across all phases of research and discovery, development, validation and approval. Based in Germantown, Maryland, the offices are within easy reach of the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA).
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Contact Amarex Clinical Research at info@amarexcro.com or +1 301 528 7000
Amarex Clinical Research, an NSF 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, Maryland, the offices are within easy reach of the National Institutes of Health (NIH) and the U.S. Food and 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 and FDA applications (IND, IDE, 510(k), NDI, NDA/505(b)(2), ANDA, BLA and PMA). We can also act as a U.S. agent to FDA for correspondence, meetings, presentations and negotiations, and provide data safety monitoring committee and clinical ethics committee management, auditing for FDA and ICH compliance (GLP, GCP, GMP and GAP), training seminars and consulting on regulatory strategy, statistics, study design, CMC, etc.
Amarex Clinical Research is an expert CRO, expediting patient access to safe and effective clinical products.
