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Amarex Clinical Research

20201 Century Blvd., Suite 450
Germantown, MD, USA

Category: Clinical Trials Services (CRO); R&D Services

Used in the following map:

Maryland Biotech Industry Map

Amarex Clinical Research is a contract research organization that provides clinical regulatory strategy and product development services for drug, medical device and diagnostic kit approvals in the U.S. and other countries.

Amarex's service areas include: regulatory, clinical trial conduct, biometrics and medical writing. Its regulatory services include: clinical site, manufacturer site and laboratory audits - GCP, GMP, GLP, chemistry & Manufacturing Controls (CMC) consultation for FDA compliance, regulatory strategy creation for clinical product development, FDA meetings and presentations, and U.S. agent to FDA for non-USA companies - annual IND reports, drug master file updates, etc. Its clinical trial conduct services include: trial planning and project management, protocol development, investigator meetings, IRB assistance, clinical monitoring, etc. The company's biometrics services include: ICH E9 compliance, CRF design (EDC or paper), database design and creation, data entry & cleaning, statistical analysis plan, analysis tables, listings, graphs, etc.

Amarex offers services in the following product categories: biologics, botanicals, combinatorial biotech products, diagnostics, medical devices and pharmaceuticals (small molecules / new chemical entities). The company has expertise in the areas of: cardiovascular, central nervous system (CNS), dermatology, gastrointestinal, infectious disease, metabolic, oncology, pain management, pulmonary, urology and wound healing. It's WebView(SM) clinical trial management system offers patient enrollment and randomization, CRF, DCF and regulatory document viewing, trial status reporting, tables & listings review, SAE processing, drug re-supply, study bulletin board, etc.

Amarex has collaborations with OmniComm Systems Inc, Vedic Lifesciences Pvt. Ltd and Rexahn Pharmaceuticals Inc.