VPSCRO--No 1 CRO for global trials in China,VPS-CRO, an independent CRO company and member of Venturepharm Group, is one of the Asia’s leading and China’s largest pre-clinical, clinical development and product commercialization service organizations with more than 40 office sites and facilitates in Asia.
It is the largest and the only publicly traded CRO in China, as well as one of the most prestigious institutions for traditional Chinese medicine research and biotech clinical development. VPS has become one of the most professionally recognized CRO with largest numbers of projects completed and ongoing.
- Largest and only public CRO in China.
- Leader in study of oncology, CNS, cardiovascular, diabetic, GI, respiratory and allergy
- No.1 regulatory affair team for last 8 years with proved record of 500 successful project applications with SFDA
- The only integrated CRO with central analytical lab, phase I lab, animal lab, and the largest data management team
- 36 of the top 50 Pharma in China, 20+ of Global Pharma and Biotech as their customer basis
Comprehensive service centers
- VPS Pre-clinical Center
- VPS Clinical Pharmacology Phase I Center
- VPS Clinical Trials Management Services Center
- VPS Central Laboratory Center
- VPS Data Management and Biometric Analysis Center
- VPS Regulatory Affair Services Center
- VPS QA QC Center
- VPS Post Marketing Clinical Services and Phase IV Center
VPS International Team Consultant
Georges Halpern ,
Member, National Academy of Science, USA , M.D, Ph.D.
Georges M. Halpern got his M.D and Ph.D from The University of Paris. He served as outside consultant for WHO and conducted research in Allergy , Immunology, psychopharmacology, nutrition and public health. After a Visiting Professorship and Research Scholarship at Stanford University(1981-1983), Dr.Halpen was Adjunct Professor of Medicine at the University of California Davis(1983-1987), and Professor of Nutrition, College of Agriculture & Environmental Sciences(1994-97).
Georges M. Halpern has published seventeen books, 56 books chapter 138 original papers, and hundreds of reviews and abstracts. In 1985, he was awarded the Medal of Vermeil by the City of Paris for his outstanding contributions to medicine, dedication to patients and personal achievements. He has worked or lectured in 76 different countries. He works as a consultant for VPS Group at present.
Dashan Liu, Ph.D.
Dr. Liu got his Ph.D in organic chemistry from Leicester University. He conducted research on chemosynthesis in UCSDï¼University of Cincinnati College of Pharmacyï¼ Transcell Technologies, Inc.ï¼Intercardia, Inc. (1990-1998). Dr. Liu holds 7 patents in US and Europe, and has published seventeen research papers on chemistry and biopharmaceutics in science magazines globally issued. Prior to joining the Group, he has been engaged in Oracle/Oracle Clinical data management programming, SAS programming, CRF design ,EDC design and applying, and data encoding in Ingenix Pharmaceutical Service, Inc.ï¼Client Service International, Inc.ï¼Octagon Research Solutions, Inc. Dr. Liu has extensive experience on clinical research.
Xuemei (Maria) Song, M.D, Ph.D. R.pharmacist. MA.
Dr. Song is President of VPS Group. Dr. Song studied at Peking University and Peking Union Medical College, and got a Doctor of clinical medicine degree. Dr. Song also holds an MBA from Central University of Finance and Economics. Dr.Song has over 15 years experience and conducted lots of global multi-center clinical trials and local registration trials as well as Phase IV study. She was former general manager in a famous pharmaceutical company in China
Mr. George Peng is VP of Finance, responsible for the investment and finance of the group. He holds a Master of Financial Management degree from Durham University and trained CFA courses. Before joining the Group, he was the Senior Manager of a Chinese commerce institution in America, in charge of international trade and investment, and was the Chief Representative of British Stockcube financial investment consulting company in Asia-Pacific Area, as well as a co-founding partner of II Global Consulting, responsible for corporate finance and international partnership services. He has more than ten years of experience in financial investment in America and the U.K.
Mr. Steven Nelson, MBA.
Mr. Steven Nelson is the VP of Global business Development. Mr. Steven Nelson was the manager of clinical trial in SCHERING PLOUGH and the former Director of Director, Global Outsourcing Operations in Pfizer. Steven holds M.B.A from New York University, and B.S. of Biology from Fairleigh Dickinson University. Mr. Steven Nelson has extensive experience in outsourcing, project management, and leading effective teams.
Chengxiang Daiï¼M.D, Ph.D
Dr. Dai got his Ph.D. from the postgraduate school of PLA General Hospital and worked there as a chief physician in cardiovascular department. He has been engaging in clinical medical treatment, medical affairs and scientific research for about 20 years. His publications include 40 research papers and two academic works as a cooperating writerï¼Dr. Dai had won a tech-advance prize in Beijing city, a couple of technology progress prizes as well as a medical care achivement prize in PLA. Before joining Venturepharm service CRO group, Dr. Dai had been working as a manager in a large multinational pharmaceutical company and conducting many clinical trails on antihypertension new drugs and new hypoglycemic agents. He has rich experience in pharmacogenomics research, clinical trials and intellectual property rights. Dr. Dai is Medical Director of VPS, engaging in clinical trials design and new drugs development.
Lianping (Peter) Hu, Ph.D.
Dr. Hu graduated from China Medical University. Before going overseas for further study. Peter worked for Military Academy of Medical Science. Peter got his Ph.D on Biometry from the London University. Before joining VPS, Dr. Hu, as the Chief Statistician and had been working for ICOM, C&C in Canada. Dr. Hu is the Manager of the Center of Data Management and Biometric Analysis.
Funan Huang, M.D, Ph.D.
Dr. Huang graduated from First Military Medical University, and got his Ph.D. from PLA 301 Hospital. Dr. Huang did his post doctoral research in Thomas Jaferson University, USA. Before joining Venturepharm, Dr. Huang was working, as the manager, in a large Japanese pharmaceutical company. Dr. Huang is the Manager of the Center for Pharmacology and Clinical Pharmacology in VPS.
BuLin, M.D. Ph.D.
Dr. Bu graduated from Tsukuba University in Japan, and got his M.D degree. He has taken EMBA courses in Renming University of China and got its certificate. He has been engaging in Medical Affairs for above twenty years. Before joining Venturepharm, Dr. Bu served in a large Japanese pharmaceutical enterprise for five years, Then he worked as the General manager, in a well-known domestic pharmaceutical company. Dr. Bu has extensive experience in Medical Affairs and Marketing Administration. He is the Business Manager in VPS
One of the five most promising companies in China--Fortune
Winner of entrepreneur and innovation 2004--British Chamber
Forerunner in new drug development -- China MedPharm News
Winner of 2004 en best management Elites-- Central Government, China
2003 Best run joint venture-- Association of JV
The preclinical service center staff of VPS holds a medical and/or pharmacy degree, well trained in GCPï¼GLP and all other relevant ICH and FDA guidelines. As a full-service preclinical contract research organization, VPS can offer full service preclinical trials with highly quality and wide areas, we can also provide the data in compliance with trials to FDA and/or SFDA. With rich experiences, we have completed tens of preclinical study items.
Acute toxicity study
Long-term toxicity study
Safety pharmacology study
Hyper-sensibility and haemolyticus test
Reproductive toxicity test
General reproductive toxicity test
Sensitive period to teratogenic agent
Peripartum reproductive toxicity test
Genetic toxicity test
Chromosomal aberration test
TK gene mutation test
Gene mutation test
Primary cell culture
The study on genes related to toxicity
The study on proteic mass spectrometry related to toxicity
· Disease models
Psychic and nervous system
Gynecologic and obstetric system
The detecting on index related to urine, sedes and other body flow
The detecting on cytology, biochemics and haematogenic immunity of blood samples
·Methods of analysis and detection
Immunoassayï¼ELISA (enzyme-linked immunospecific assay)ãRIA(radioimmunoassay)ãEIA (electroimmunoassay)ã IRMA(immunoradiometric assay)
Clinical Research (Phaseâ
Clinical Pharmacology has been central to VPS 's services since we were founded in 1998.They has helped a lot of clients successfully manage the transition from non-clinical to early clinical development.
Their specialtyï¼Professional Clinical Pharmacology Support for Clinical Trials
VPS offers Professional Clinical Pharmacology Support for Clinical Trials. Their clinical pharmacology group is skilled and experienced in the analysis and interpretation of PK/PD data, providing assessment of clinical relevance and insight into results for use in drug development decisions. They carry out early human administration of your compound with unsurpassed precision, using their highly qualified experts, large subject database of healthy volunteers, and special populations. Their collaboration with most famous academic hospital departments gives them additional access to expertise and patient populations, all of which ultimately accelerates drug development process. Data generated by Clinical Pharmacology research centers are wholly acceptable by the SFDA – exactly the type of you need.
They offer comprehensive Phase I-IIa clinical trial and Bioequivalence (BE) project management. Their clinical pharmacology expertise as part of an integrated drug development program or as a discrete stand-alone service, with clinical, scientific and regulatory experience in:
Clinical PK program development
Generic drug development
ANDA bioequivalence (BE) project management
Design and analysis of PK studies, with emphasis on in vivo/in vitro correlations
PK training for clinical project teams and specialized training for CRAs in critical
First in human studies
Compartmental and noncompartmental PK analysis and modeling
In vivo/in vitro correlations Average population and individual bioavailability (BA) and bioequivalence (BE) assessments
Review of all PK parameters and concentration-vs-time profiles Evaluation of linear and nonlinear pharmacokinetics
·Clinical and statistical reports
Clinical Research (phaseâ
Up to now, VPS group has successfully completed more than 100 of projects including clinical trails phaseâ
£, Pharmacokinetics research, Bio equivalence research and In-vivo analysis research and so on. VPS group has obtained more than 10 of the import registration certificate. The therapeutic areas involve endocrine system, CNS, CVS, digestive system, anti-infection, anti-cancer and so on, and the investigational products include chemistry medicine, Chinese traditional medicine, biological products and medical device and so on. At present, VPS group simultaneously conduct 70 projects, among which 6 are innovative medicine. There are some examples below.
Clinical Trial Services include
·Drug Development Planning
·Trial Design CRF Design
·Study/Recruitment Feasibility Assessment
·Organization and Conduct of Phase I/II-IV Clinical Studies
·Medical Monitoring Services
·Central Nervous System (CNS)
Data Management and Biometrics
Effective Solution Provider
·Validated paper-based data management
·Design of CRF and data bases.
· Data entry.
·Data validation plan.
·Programming of queries.
·Support for study report.
· Data and query management.
·Calculating sample size requirements.
·Developing plan for interim analysis, if needed, and for final analysis(including sub-analyses).
·Determining how interim analysis results impact sample size.
·Perform analysis and data evaluation.
·Write statistical report.
They can design CRFs efficiently to get reliable data for primary and secondary endpoints. The study database is built based on a SAS-annotated CRF.Efficient data management can speed the entire clinical trial process and increase data collection accuracy and consistency while reducing costs.Custom electronic tools for data entry and query management along with a highly trained and experienced staff ensure accuracy as evidenced by impressive data validation results.Additionally, our specific knowledge ensures that data management procedures conform to U.S. and international regulations.
All of the data management systems are 21 CFR Part 11 compliant. Because their data management of function is an integral part of the clinical trial management team, it can be tailored to meet the requirements of specific studies as well as differing business requirements.
·CDISC mapping: Regulatory submission datasets in the world of evolving standards.
·Comprehensive staff training.
· Prepare and review application dossiers.
· Translation services.
· Domestic drug, biological products, health food, medical devices and pharmaceutic adjuvant registration and renew.
· Import drug, biological products, health food, medical devices and pharmaceutic adjuvant registration and renew.
· Project feasibility evaluation.
· Regulatory education and training.
· Liaison with regulatory authorities.
· Approach to regulatory authorities for consultation.
Venturepharm has an experienced registration team and has succeeded in the last 8 years in registering 400 domestic products and 20 import products.
· 347 clinical trials approved
· 63 marketing approval obtained
· 20 import registration license obtained
· High quality personnel
·Their team has built strong relationship with various government agencies through its longtime activities .
·Their overseas clients including Daewoong in korea , Ranbaxy, Lupin and Workhardt in India, Sofradim in France, Rohm in Germany , AMSA in Italy and Fako in Cuba as well as in EU, USA and Japan via our global alliances.
APEX’s regulatory team can provide the following benefit:
Worldwide/Regional regulatory strategy making
Liaison with regulatory authorities
Approach to regulatory authorities for consultation
Environment risk assessment
Plant Master File (PMF)/ Site Master File (SMF) application
Quality System Documentation (QSD) application
Good Manufacturing Practice (GMP) application
Validation Document application
Bridging Study application
Clinical trial submission
Pharmaceutical product registration
Medical device registration
Health food/cosmetics registration
Post marketing amendment application
Design/translate of ICF
Role as license holder for sponsors
Regulatory education and training
On site regulatory services
· Documentation and preparation for NDA
· Imported drug registration
· Imported medical device registration
· Regulation policy consultation
· Project feasibility evaluation
· 247 clinical trials approved
· 63 marketing approval obtained
· 16 import registration license obtained