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
