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COMPANY DETAILS » APEX International Clinical Research Co., back to previous page show list

APEX International Clinical Research Co.,

address: APEX International Clinical Research Co., Ltd.
3F,No.510, Sec.5, Chung-Hsiao E. Rd., Taipei 110, Taiwan, R.O.C.
contact: APEX China (Shanghai)
APEX China Co., Ltd.
No. 2202-2206, 22F, East Tower, Zhong Rong Heng Rui
International Plaza, No. 620, Zhang Yang Rd., Pudong, Shanghai, China 200122
TEL : +86-21-6160-9090
FAX : +86-21-6160-9191

trunover in millions USD: 0
R & D turnover in millions USD: 0
NET profit: 0
year of financial results:
employees: 350

active in China: YES

SFDA approved: NO

Approvals:
GLP: NO
GMP: NO
AAALAC: NO
SEPA: NO

Activities engaged in:
Manufacture: NO
Active Pharmaceutical: NO
R&D: NO
Ingredients: NO
Western Generics: NO
TCM: NO

R & D:
Discovery: YES
Work Up (pilot to production): YES
Analysis: YES
Quality Control: YES
Stability: YES
Batch Release: YES

Clinical trials:
Run/Manage: YES
Data management: YES
Support Labs: YES

Non clinical & preclinical:
Animal Testing: GLP: NO
New materials Safety Assessment: NO
Pharmaceuticals: NO
Agrochemicals: NO
Industrial & Other Chemicals: NO
Non GLP - Discovery ADME: NO

Chemistry-contract manufacture:
Generics: NO
API: NO
Licensed Drugs: NO

test:
R&D: NO
 
Overview:
APEX is a leading CRO operating in Taiwan, China (Shanghai, Beijing and Hong Kong), Korea, Singapore, Malaysia, Indonesia, India, Thailand, Philippines, Australia and New Zealand. Their pan-Asia presence enables sponsors to grasp all necessary information and quality services in conducting trials in Asia.
 
APEX's dedicated team of well trained clinical research professionals in the areas of International Project Management, Regulatory Consultatoin and Submission, Clinical Monitoring, Biostatistics, Statistical Programming, Clinical Data Management, Medical Monitoring and Writing, Clinical Trial Auditing, GCP/Clinical Trial Training and Feasibility Study. Working for clients worldwide, APEX applies its expertise in clinical research and offers the best possible solutions and valuable insights into the clinical and commercial potential of new products.
 
APEX's vision is to establish the most professional and competitive CRO team in the Asia-Pacific region for clients worldwide. They are experienced with Asia-Pacific regulatory authorities and have good relations with most major medical centers and hospitals in the region. In conformity with the ICH-GCP guidelines, their Clinical Research Associates have efficiently assisted their clients in monitoring clinical trials.
APEX also has enhanced capabilities through alliances and partnerships, throughout Europe and North America. As the largest and most professional CRO in Asia, APEX has successfully provided a full range of pharmaceutical development services to assist more than 150 pharmaceutical, biotech, and medical device companies worldwide, by either expediting their global clinical trial timeline or bringing their new products to the Asian market.
 
Today APEX has almost 350 employees who have a broad experience in a number of therapeutic areas, including endocrinology, infectious, oncology, dermatology, cardiology, respiratory, gastroenterology and nervous system disorders. As members of academic, pharmaceutical and clinical research organizations, APEX’s staff has played key roles in the clinical development of several products currently on the market.
Unlike other large CROs, APEX operates on a personal scale to avoid bureaucratic layers that would impede the flexibility of our services. This distinct advantage enables their staff to be easier accessible and responsive.
Service
Chemical monitoring
At APEX Clinical Research Co., they provide a complete range of clinical monitoring services.  Depending on the needs of the clientele, APEX offers its services either as a comprehensive package or on a flexible per service basis.
 
Clinical Research Associates with two years of full time experience with APEX are encouraged to meet the international standard of qualification through ACRP accreditation and certification.  Thus, APEX continually strives to provide clientele services at a high standard of quality, delivered on time and on budget.
 
The spectrum of clinical monitoring services provided by APEX is performed in accordance with ICH-GCP guidelines and protocol, and includes the following:
 
Pre-study document collection and review,Site selection,Pre-study site visits,Initiation visit,Monitoring visits,100% source document review and data verification, quality control reviews, drug storage / accountability, data verification and query resolution,SAE reporting,Close-Out visits
Monitoring reports
 
Proget Management
 
At APEX Clinical Research Co., the project managers have been thoroughly trained on every aspect of clinical project management. With experience and daily practice in communicating with international sponsors, their project managers / directors are not only highly knowledgeable in the field of clinical trials but also proficiently skilled in English language communication.
 
Overseeing all aspects of global clinical research projects,Management of Investigator grants,Local regulatory authority/IRB coordination and submission,Regulatory document processing and tracking,
Vendor selection, coordination and management,Study-specific clinical personnel training for Investigators and Coordinators,Coordination of Investigator Meetings,Development of site or study-specific subject recruitment strategies and programs(including contingency strategies/solutions to address specific project challenges),Communication with sponsors and study sites,Study budget management
Regulatory Affairs
Their regulatory affairs staff comes from a wide range of therapeutic backgrounds in across Asia. They can assist you in strategizing, designing, preparing, submitting and defending your submissions to the regulatory bodies in around Asia .The regulatory affairs group at APEX consists of individuals with intimate working knowledge of local regulatory authorities. They can advise the client on the most efficient way to design and conduct the development program to maximize the success during all clinical phases. They can also help the client develop strategies and employ tactics to deal with emerging regulatory issues that arise during the product development cycle.
 
APEX’s team has the capabilities and experience to offer a comprehensive range of regulatory services for countries in the Asia Region including: Taiwan, China (Shanghai, Beijing and Hong Kong, Korea, Singapore, Malaysia, Indonesia, India, Thailand, Philippines, Australia and New Zealand).
Strategy Consultation
Worldwide /Regional regulatory strategy making
Liaison with regulatory authorities
Approach to regulatory authorities for consultation
Environment risk assessment
Product evaluation
 
Regulatory Services
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
Import licensing
Translation services
Design/translate of ICF
Role as license holder for sponsors
Regulatory education and training
On site regulatory services
Project management
 
Medical Affairs
To ensure valid and robust outcomes of a clinical trial, the medical expertise at APEX get involved in the study in the earliest phase possible. This increases the overall efficiency and reduces the need for sponsor oversight and review. Their medical affairs experts work closely with internal statisticians and clinical research associates to develop study protocols, investigator brochures and ready-to-submit final reports.
 
Constructing and developing study protocols
Assistance in design and development of Investigators brochure 
Preparation of study final reports phase I-IV in accordance with
FDA and /or ICH-GCP guidelines
Reporting and documenting clinical adverse events
Preparing pre clinical studies, including drug development plan and study budget
Administering safety monitoring
Statistical analysis
 
From database design to data analysis, APEX team members assist clients in achieving reliable, verifiable statistical results. Their statistical analyzers are customized to the project specific requirements, from sample size estimation and consultation, central randomization, protocol design to study results interpretation.
The statistical services of APEX Clinical Research Co. are validated and comply with ICH-GCP guidelines. They use SAS as the standard tool for statistical programming of tables, listings and figures.
Consultation on protocol and CRF
Protocol design on statistical methods
Randomization code generation
Sample size calculation and power analysis
Statistical analysis and data listing
Statistical analysis
Stand-alone statistical report writing
Integrated statistical/clinical reports
Submission support
 
Quality Assurance
Quality has been the cornerstone of the services they provide. They believe that quality in their service tops their list of priorities. Their Standard Operating Procedures are in compliance with Good Clinical Practice, and conform to the highest standards. To ensure a continued high level of consistency and quality, APEX has implemented a comprehensive quality management system. Their services include QA consulting and QA audits performed by experienced quality management specialists.
Investigational Site Audit
Computer System Audit
Subcontractor Evaluation
GCP and Audit Training
Location
 
APEX Headquarter
APEX International Clinical Research Co., Ltd.
3F,No.510, Sec.5, Chung-Hsiao E. Rd., Taipei 110, Taiwan, R.O.C.
TEL : +886-2-2727-1100
FAX : +886-2-2346-5211
bd@apex-cro.com
APEX China (Shanghai)
APEX China Co., Ltd.
No. 2202-2206, 22F, East Tower, Zhong Rong Heng Rui
International Plaza, No. 620, Zhang Yang Rd., Pudong, Shanghai, China 200122
TEL : +86-21-6160-9090
FAX : +86-21-6160-9191
APEX China (Beijing)
APEX China Co., Ltd.
Room 1115, 11F, Yi No.12, Chao Yang Men Wai Street ,Chao Yang District , Beijing , China Kuntai International Mansion Building,100020
TEL : +86-10-5879-7676
FAX : +86-10-5789-7672
 
 
 

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