Provision of services by a reliable CRO with sufficient experience and capability.
Our company has sufficient experience and capabilities, and we have entered into business contracts with two reliable CROs to support your clinical trials. 1. Company A (Trials in North America, Europe, and South Korea) With four locations in the United States, four in the EU and Switzerland, and one in South Korea, we provide global trial services and have received positive feedback from many Japanese pharmaceutical companies for being accurate, high-quality, fast, and cost-effective. In global trials, we have experience with 1,000 protocols across approximately 30 countries. 2. Company B (Trials in Taiwan and China) Based in Taiwan, we have been conducting clinical trials for over 30 years since 1988, covering both low-molecular and high-molecular drugs. Clinical trials in Taiwan can be conducted at significantly lower costs compared to those in Japan and Europe, offering the following advantages: - By conducting trials as part of studies in Japan and Europe, case acquisition becomes easier, and the trials can be expedited. - Results from trials conducted at four designated hospitals in Taiwan can be used to apply for approvals from the Chinese government. - Due to long-standing relationships with East Asian and Southeast Asian countries, entering the functional food market in these regions becomes easier.
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basic information
1. Company A (Testing in North America, Europe, and South Korea) - Has a track record of approvals from US FDA, EMA, OECD, PMDA, and others. - Has over 40 years of experience in clinical trials, owns approximately 600 beds, and is capable of conducting not only Phase I to II proof of concept (POC) trials but also Phase III to IV trials. - Has experience with cancers (over 25 indications), immune disorders, infectious diseases (bacterial, viral, etc.), various diseases of the liver, kidneys, and respiratory system, as well as obesity and diabetes. - In addition to biomarker analysis and PK/PD studies, testing for immunogenicity, antigenicity, and immunotoxicity is also possible. It can establish over 100 analytical methods per year and has the capacity to analyze approximately 600,000 samples annually. 2. Company B (Testing in Taiwan and China) - Inspected by US FDA, TFDA, OECD, PMDA, NPRA. - Capable of conducting Phase I to IV trials for pharmaceuticals. - Testing for medical device application. - Analytical equipment owned includes UPLC-MS/MS, LC-MS/MS, ICP-MS, ELISA, etc.
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Applications/Examples of results
1. Company A (Testing in North America, Europe, and South Korea) - Approval records from US FDA, EMA, OECD, PMDA, etc. - Capable of testing low molecular weight drugs, high molecular weight drugs (including vaccines), radiolabeled drugs, etc., with over 6,000 testing experiences to date. - Clinical experience in cancer (more than 25 indications), immune disorders, infectious diseases (bacterial, viral, etc.), various diseases of the liver, kidneys, and respiratory system, as well as obesity and diabetes. - Experience in biomarker analysis, PK/PD testing, as well as immunogenicity, antigenicity, and immunotoxicity testing. 2. Company B (Testing in Taiwan and China) - Inspected by US FDA, TFDA, OECD, PMDA, NPRA. - Conducting Phase I to IV clinical trials for pharmaceuticals. - Testing for medical device application purposes.
Company information
Libra Medicina Co., Ltd. aims to contribute to the improvement of health and quality of life for people around the world by being involved in the creation of innovative pharmaceuticals and medical devices through development support services and licensing activities, delivering hope to patients suffering from serious diseases.
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