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History of VCRO

2014
Successfully registered to US FDA a Phase I/IIa IND in CTD format
Successfully registered to US FDA a Phase I 505(b)2 IND in CTD format
2012
Established Alliance for Pac-Asia Clinical Trials (A-PACT) with ACM (JP), C&R (KR), and Rundo (CN)
Successfully registered to US FDA 2 phase II INDs achieved clinical-go and filed 2 US IND amendments in Phase I & II
Expand broader Lead CRO service for multinational studies, under US FDA IND
2011
Accredited by Taiwan DOH GLP for Bio-analytical Laboratory
Launched eCTD Service
Established JOVIA Ltd. by VCRO and C&R particularly for Asia-Pac regional study
2010
Launched VCROCTIS version 2, which included SAE Tracker, and Asian characters supported in e-CRF and clinical data
Launched VCROIWRS Service
Partnering with C&R CRO (Korea)
Partnering with SIRO CRO (India / Europe)
Successfully registered to US FDA IND phase I IND for 1st Taiwan initiated New Chemical Entity (NCE) by Common Technical Document (CTD) format
Expanding OECD & US FDA GLP Bio-Lab services to US IND studies
2009
Accredited to OECD (Organization for Economic Cooperation and Development) GLP for Bio-analytical Laboratory
Acquired Oracle Clinical (OC) a clinical data management system
2008
Formally launched VCROCTIS (EDC + Clinical Trial Management) service
2007
Accredited to ISO/IEC 17025:2005 for Bio-analytical Laboratory
Accomplished VCROCTIS (Electronic Data Capture & Clinical Trial Management) for real project pilot-run
2006
Involved more US-FDA IND studies
Contracted with record large scale study ( ~2000 patients in >150 sites, >18 countries)
Initiated interactive voice response system (VCROIVRS) service
2005
Granted > 3 millions USD for co-establishing Clinical Research Center for Stroke & Traumatic Head Injuries in Taiwan (Sponsored by the Dept. of Health)
The only CRO in Taiwan with 100% approval record in ICH-GCP quality inspection
2004
Rated as the best CRO by the National Science and Technology Program
Initiated IT program of developing FDA 21 CFR Part 11 compliant Electronic Data Capture System & Knowledge Management System (Partially sponsored by the Ministry of Economic Affairs)
Acquired VCRO's own office/laboratory
Established formal collaborative alliance with Japanese CRO
2002
Expanded into clinical trial business to include the Asia-Pacific region
2001
Established the bio-analytical laboratory and launched services for Phase I study (PK/PD) and BA/BE
2000
Increased capital size for the first time that quadruples the initial investment
1997
Founded in Taipei, Taiwan. Launched clinical services in Taiwan and pioneered clinical trial training programs to personnel from pharmaceutical/biotech industry
二八连码三中二猜生肖