乐动体育南安普顿

Services by CompanyAmarex Clinical Research

乐动体育南安普顿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, Maryland, the offices are within easy reach of the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA).

乐动体育南安普顿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.

乐动体育南安普顿Amarex Clinical Research is an expert CRO, expediting patient access to safe and effective clinical products.

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+1800 NSF MARK (800 673 6275)

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