With rich experience in the design, organization and implementation of bioequivalence (BE) studies, as well as good understanding of FDA regulations, Axeon can successfully help the customers to complete the bioequivalence studies in accordance with the requirements of CFDA or US FDA.

Our Advantages:

• Multiple successful bioequivalence studies gained regulatory approval by the FDA or EMA.
• Close cooperation with worldwide phase I clinical research bases.
• Extensive experience in projects management for BE studies.

Our Services:

• Professional clinical trial design.
• International standards for clinical trial management throughout the study.
• DM and Biostatistics services that meet the FDA regulatory requirements.

The challenges of conducting and managing global multicenter clinical trials have never been greater. With extensive experience, our team can proactively identify and manage or mitigate the risks emerging pre, during and post the studies in a timely fashion to achieve the goals of the trials. Our team, with world class experts experienced in broad therapeutic areas and regulatory policies, will optimize the study plan and the study team. Our close cooperation with global clinical trial sites, the compiled clinical center databases and patient databases will ensure efficient patient recruiting and fast initiation of clinical study and generate high quality clinical data.

Our Advantages:

• The service covers many countries and regions including China, US, Canada, Russia, Europe, Australia, Taiwan, etc.
• Completed a phase II, III clinical research trial in the US for a modern Chinese medicine, the first of its kind--multi-herbal drug product.
• Close cooperative relationship with numerous well known domestic, US and EU clinical trial institutions.
• Own all-functional professional team in US.

Our Services:

• Completed phase II and III clinical research trials in the US for a modern Chinese medicine, the first of its kind--multi-herbal drug product.
• Phase I-IV clinical study design and protocol development.
• Implementation of clinical trials, including preparation of essential documents, site selection, organization of investigators’ meetings, IRB submission, patient recruitment, data management and biostatistics, etc.
• Clinical trial management (monitoring, safety reports, quality control, clinical study report, etc.).

With abundant practical experience on the improvement for a number of large domestic clinical bases to be the international standard clinical research center, we provide the full range of integrated services according to the unique needs of the clinical base, including the scheme establishment, training on the related laws and regulations, the improvement of the SOPs and base simulation assessment and so on that strictly adhering to international standards.

Our Advantages:

• Illustrated numerous successful cases to improve clinic sites to meet international cGCP standards.
• Tailored scheme of standard improvement of clinical trial base.
• Close cooperation with worldwide clinical research bases.

Our Services:

• Standardized assessment of the clinicalresearch center.
• Rectification of scheme to meet international compliance standards.
• Establishment and improvement of the data management system.
• Simulation assessment before FDA on-site audit.
• Establishment and improvement of the SOPs system.
• Training on international laws and regulations.

Axeon acknowledges that data management is of paramount importance in the entire process of clinical development. We have established an excellent cooperative relationship with the leading supplier in the market, utilizing the advanced and forefront EDC system. Meanwhile, we have independently developed a data management system in compliance with international standards and the latest requirements. High quality and professional service will be provided.

Our Advantages:

• Compliance with CDISC standard and FDA, EMA data requirements.
• Extensive data management experience in global multi-center clinical studies.
• Data management lifecycle which meet the CSV requirements.
• Compliance with CDISC standard and FDA, EMA data requirements.
• Professional, efficient, highly cost-effective service.

Our Services:

• Customized technical solutions.
• P-CRF and E-CRF design.
• Self-explanatory CRF database design and CDISC standard.
• Database design and setup.
• Database quality control.
• Laboratory data mediation.

Axeon bio statistical team has highly qualified and dedicated biostatisticians and programmers, with extensive knowledge of clinical study design, statistical methodologies and international registration regulations. We provide timely study reports of high quality and overall analysis; consultation service regarding study design, scale and execution, etc. Additionally, we also ensure that all design and analysis methods fully comply with the latest regulatory requirements.

Our Advantages:

• Generate SAP documents that best fit the characteristics of the products.
• Proficient in the latest regulations of FDA and EMA to ensure all analysis results meet the requirements.
• Highly scientific and dependable project design and accuracy of statistical analysis.

Our Services:

• Sample size calculation.
• Randomization schedule and encoding.
• Statistical analysis plan.
• Statistical programming.
• Data CDISC conversion.
• Tables, Figures and Listings (TFLs).
• Interim analysis.
• Statistical analysis report.
• Statistical communication with regulatory agencies.
• Integrated summary of efficacy and safety (ISE/ISS).

Axeon will provide you with brand promotion, strategy development and industry positioning and other macro-layout planning with a wealth of marketing experience and broad overseas market resources of our parent company. We can conduct overall and in-depth market research and analysis, development and implementation of marketing programs, to help you enter the overseas markets and achieve your goals.

Our Advantages:

• Long-term supply agreements with the tens of thousands of drugstores of 4 large US chain pharmacies.
• Have a joint venture with a famous healthcare products distributor.
• Diversified sales channels.
• Localized marketing team.

Our Services:

• Industry analysis.
• Product analysis and selection.
• Product specification, packaging design and transportation.
• Overseas marketing strategy.
• Marketing strategy implementation.

Axeon was established on the basis of strong capital of 5 billion RMB. We will locate valuable investment opportunities based on our extensive brand, strategic development experience and provision of financial support for small and medium enterprises.

Our services - License-in & Promotion:

• Perform marketing survey in different countries.
• Facilitate the establishment of Industry-Academic collaborations.
• Promote the collaboration of domestic industry firms with oversea partners.

Our services - Investment & Financing:

• Screening valuable investment opportunities and enterprises.
• Providing professional assessment and consultation services with regard to target companies.
• Integrated boost services and cooperation.
• Technical and financial support.
• Contact with domestic/international third-party investment institutions and provision of qualification reports.
• Market agents for contracting.

Axeon understands that audits play an important role in the quality control of clinical trials. We have experienced American auditors who will conduct the audit in strict compliance with FDA, EMA and CFDA regulations. We also provide systematic audits of Phase I-IV for both national and international clinical trials, to ensure the integrity and compliance of the clinical study.

Our Advantages:

• Independent third-party audit team.
• Full-scale or single project audits to meet a wide variety of needs.

Our Services:

• Clinical trial center audits.
• Clinical study document reviews.
• Clinical database and statistical audits and study report reviews.
• Vendor audits including central lab, drug logistics provider, IWRS/IVRS etc.

Axeon has established a system of close international communication and training cooperation with world famous universities such as Johns Hopkins University,Columbia University and The University of Nottingham and medical research institutions including National Institutes of Health (NIH), Association of Clinical Research Professionals (ACRP), etc. The program provides the directors of hospitals, principal Investigators, senior healthcare executives etc. with professional, short-term training and on-the-spot investigation concerning medical management and clinical trials. All of which provide in-depth experience on laws, regulations and trial management which is necessary for institutions with global operation.

Our Advantages:

• On-the-spot investigation centered primarily on face-to-face communication.
• Tailored international training courses, customized to specific needs.

Our Services:

• On-the-spot investigation.
  • US clinical trial sites.
  • US National Institutes of Health (NIH).
  • Medical institutions such as hospital of Johns Hopkins University.
• Scope of training
  • Promotion for medical administrators, courses such as:
    • Supervision and management of clinical treatment.
    • Hospital operation and management of financial indicators.
    • Technology and innovation in patient care.
  • Clinical trial management courses such as:
    • Risk assessment on GCP compliance.
    • Quality control of clinical trials.
    • Budget management of clinical trial base.
    • Safety and management of the subjects.

In recent years, Pharmacometrics plays an important role in new drug R &D. We have many experienced experts with extensive knowledge of pharmacometrics in our team. We provide timely consultation service regarding clinical outcome prediction, study design, and design optimization, and precision medicine for special populations. Additionally, we also ensure that all design and analysis methods fully comply with the latest regulatory requirements.

Our Advantages:

• FDA highest ranked Expert Scientists / Reviewer in Pharmacometrics.
• Co-Chair and then Chairman of FDA/CDER Guidance of Population Pharmacokinetics.
• Experts who have directed tens of Pharmacometrics studies.
• Member of Chinese and American Pharmacological Society.

Our Services：

• Conduct modeling and simulation research by population pharmacokinetics.
• Conduct new drug clinical study design, dosage selection for special populations by the methods of pharmacokinetics.
• Conduct drug interaction studies, and clinical study in children and special populations by population pharmacokinetics.
•  Conduct dose optimization by the methods of population pharmacokinetics.

We have many experienced experts with extensive knowledge of pharmacoeconomics. We have established close cooperative relationship with key pharmacoeconomics research companies. We provide timely consultation services regarding drug pharmacoeconomics analysis, drug valuation, price definition and price negotiation with government agencies. Additionally, we also ensure that all analysis methods are fully in compliance with the latest regulatory requirements.

Our Advantages:

• Pharmacoeconomics professors from Tianjin University.
• More than 10 experts with Ph.D. or master degrees in pharmacoeconomics.
• Close cooperative relationship with famous pharmacoeconomics research companies.
• Experienced in price negotiation with the National Development and Reform Commission. 

Our Services:

• Drug pharmacoeconomics analysis, drug valuation and price definition.
• Discover the advantages of the products.
• Price negotiation with government agencies.
• Generate pharmacoeconomic report for NDA in European countries.