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Orient Pharma can provide clinical study related service to help partners and sponsors whether in Taiwan or overseas (US, EU, Japan, etc.) to conduct multi-nation, multi-center early phase (Phase I ~ Phase III) clinical studies in Taiwan, Hong Kong and Singapore according to GCP, study protocol, sponsor’s SOPs and applicable regulations.
General Activities | |
Provide advices on clinical study strategies and health authorities’ requirements | |
Provide consultation for planning clinical studies | |
Conduct pre-study assessment and identify proper study sites | |
Complete qualification process for Contract Research Organizations (CRO) and clinical study related vendors | |
Conduct Clinical Project Management | |
Negotiate and complete study contract process with study sites | |
Negotiate and complete study contract process with study sites | |
Complete Institutional Review Board (IRB) or Ethics Committee(EC)’s required process for Clinical Trial Application | |
Arrange and hold investigator meetings | |
Provide study monitoring services (including Site Initiation Visit, Monitoring Visit and Site Close-out Visit) | |
Purchase of comparator for clinical trials | |
Study specific labelling | |
Current Clinical Study Partners and Sponsors | |
AndroScience Corporation | |
CEL-SCI Corporation | |
Durect Corporation | |
NanoCarrier Co., Ltd. | |
Orient Europharma Co., Ltd. | |
Pierre Fabre Medicament | |
Sansho Co., Ltd | |
Kissei Pharmaceutical Co., Ltd | |
Toray Industries, Inc. |