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PharmaCRO

Regions
Asia
Countries
South Korea
Size
n.e.
Specialty
Human Medicines
Service category
GMP audit services, GLP services, …
Service category
GMP audit services, GLP services, GCP audit services, Clinical development and testing, clinical CRO, eData - IT - software, Regulatory services - CMC writing - medical writing
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Summary

Clinical trials are one of the most important parts of the drug development process and also one of the most time-consuming processes. A Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support to the pharmaceutical, nutraceutical, biotech industry. CROs offer clients a wide range of "outsourced" pharmaceutical research services to aid in the drug, dietary supplement, and medical device research & development process. CROs have become a cornerstone of research enterprise, adhering to the highest standards of scientific quality and medical ethics. The industry has evolved from providing primarily clinical services or single- service support in clinical monitoring and data management to a full-service industry offering services from the earliest stages of development through clinical trials and commercialization of products. PharmaCRO constitute about half of the research workforce involved in drug and medical product development. We provide a wide range of clinical development services to research sponsors, including consultation with study design, investigator recruitment, study monitoring, data analysis, and IND/IRB/NDA documentation works. As experts in the clinical research process, we comply with rigorous Korean and international regulations and Good Clinical Practice (GCP) standards. We are leading clinical research organizations (CROs) in Korea that provide a full range of clinical development services and conduct research in Asian countries and approximately 15 clinical trials are conducted in Korea each year sponsored by both industry and government. We committed to demonstrating the strategic value of clinical outsourcing and the important contribution and we make as partners in the development of new medicines and new treatments.

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