ADM Korea Inc is a pharmaceutical company that provides services such as clinical operations, project management, post-marketing surveillance (PMS), regulatory affairs, data management, statistical analysis, quality assurance and audit, product development (consulting), and pharmacovigilance. Under regulatory affairs service, the company offers strategic and regulatory drug development consulting, preparation and document validation of registration dossier, scientific and medical communication with regulatory authorities, investigational new drug application (IND) and new drug application (NDA) support, and post-approval maintenance support. Its clinical operation services include protocol and case report form (CRF) development, investigator and site selection, feasibility study, and interim monitoring visit. The project management plan covers site, vendor, and document management. PMS services consist of institutional review boards’ (IRB) submission, site contract, investigational staff training, monitoring, safety report, and periodic and re-examination report writing. The company’s data management services include data management plan development, customized database design and validation, data validation and check report, medical coding, data quality reviews, electronic data transfer, and back-up and security. ADM Korea’s statistical analysis service covers statistical consulting, statistical analysis plan (SAP), randomization code generation using SAS software, and SAS software programming for result and output.
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