Orient Pharma (OP) is the subsidiary of Orient Europharma (OEP), focusing on R&D and manufacturing, and was established on Feb 1, 2008.
OP’s Clinical Research Operation (CRO) Department, established in Mar 2010, provides clinical study related services to help external partners and study sponsors whether in Taiwan or overseas countries (US, EU, Japan, etc.) to directly conduct multi-nation and multi-center early phase (Phase I ~ Phase III) clinical studies in Taiwan, Singapore and Hong Kong according to ICH GCP, study protocol, sponsor’s SOPs and applicable regulations.
- Taiwan clinical research organization (CRO) list, certified by Industrial Development Bureau, Ministry of Economic Affairs on 04 Jan 2013
- Managed and monitored multi-nation, multi-center clinical study:
Phase I ~ III TFDA or FDA or EMA IND studies in therapeutic areas including: Breast Cancer, NSCLC, Pancreatic Cancer, Head and Neck Cancer, Bladder Cancer, Type 2 Diabetes Mellitus, Hypertension, Hypercholesterolemia, Insomnia, Attention Deficit Hyperactivity Disorder, Sialorrhea, Asthma, Tuberculosis, Acne Vulgaris, Intradialysis Hypotension, etc.
- Passed Singapore Health Sciences Authority (HSA) GCP site inspection on 19-20 May 2014
- The Yunlin plant:
- PIC/S GMP approval from TFDA in July 2011
- cGMP site inspection by US FDA in April 2013
- Received “Accreditation Certificate of Foreign Drug Manufacturer” from Japan Ministry of Health, Labor, and Welfare (MHLW) in April 2012
- Provide monitoring services for clinical study in Taiwan, Singapore and Hong Kong
- Manage Phase I~III clinical projects in Asian countries
- Conduct GCP audit
- Complete IRB or EC’s required process for clinical trial application
- Source comparator and perform study specific labeling for IMP