Our global infrastructure and procedures are designed to bring projects in on time and on budget. Axzons’s local professionals have long-term relationships with leading investigator teams and medical centres and are exceptionally qualified to deliver a wide range of quality drug development services with truly global expertise
The key to simplifying your drug development journey is having a partner who is already where you need to be. At Axzons, we don’t just have more experience worldwide, we have more regulatory experience, clinical expertise, integrated technologies, and commercialization strategies in exactly the countries you need. And because our teams are all connected in real time and harmonized to the same protocols and SOPs, you get truly global thinking and results from Axzons Research every time, in every location.
Geographically, our South American locations are in major bio/pharmaceutical centers in Argentina, Brazil, Chile, Columbia, and Peru. All of these locations are growing markets for bio/pharmaceutical sales.
Good reasons to direct your development journey to Latin America include:
• Clinical trial costs average 30% lower than those in the U.S. or Western Europe.
• Large, treatment-naïve patient populations in major urban centers, including Mexico City, Buenos Aires, Sao Paulo, Bogota, and Rio de Janeiro.
• Tradition of Western medicine, familiarity with GCP standards, ICH guidelines, and clinical trials.
• Stable regulatory environment for conduct of clinical studies and approval of new therapies.
• Two languages cover the entire region.
• Seasonal reversal from North America and Europe allows “off-season” testing of seasonal disorders
• Close to the U.S., reduced travel times/costs.
• Time zones overlap with North America, facilitating communications.
Axzons capabilities in this region are comprehensive, offering full clinical development, harmonized teams using the same SOPs worldwide, advanced eClinical technologies, adept regulatory management, including import/export regulation expertise, peri/post approval services, and robust commercialization expertise. Axzons south american team knows cultural and medical practices in each country, so we can help you avoid issues that could cause potential delays.
European operations provide you with end-to-end clinical research services through every phase, integrated eClinical technologies, and results-driven commercialization services worldwide. Additionally, Axzons has in-depth regulatory knowledge and resources that can accelerate your development journey to and through the EMA, the National Health Authorities, and local Health Technology Agencies (HTAs) that are gateways to product regulatory approval and reimbursement, even as we reduce your costs and overhead.
The number of clinical trials performed in the Asia/Pacific region have increased dramatically in recent years, for several reasons, including:
• There is a larger pool of appropriate clinical trial volunteers than in Europe and North America.
• Regulatory frameworks in key Asian countries (Japan, China, Korea, Taiwan, Singapore) have evolved to promote innovation and professionalism
• Many Asian countries now have impressively sophisticated health care systems.
• A large number of highly-trained medical professionals throughout the region.
• Patient recruitment is China, Taiwan, and Korea is quite rapid now, and the data are acceptable to other regulators (FDA, EMA), as long as they are demonstrably consistent with medical practice and patient profiles in other geographies.
Asia is also the world’s fastest growing market for pharmaceuticals. Japan alone is currently the second largest bio/pharmaceutical market in the world, and China is likely to replace Japan as the second largest in a few short years.
Axzons’s broad and deep geographic coverage and rich local knowledge across Asia, represented by our thousands of employees in the region, give us the resources to support every aspect of your clinical development and market penetration in the region. Equally significant is that our regulatory experts work with government officials in each country, giving us deep insight into their improving regulatory landscape for development opportunities.
There are quality healthcare facilities and well-trained medical personnel in all of these emerging markets, with increasingly widespread GCP and ICH compliance. In the Asia/Pacific region alone, there are nearly 100,000 hospitals, more than 1 million specialized medical doctors, and nearly 4 million nurses – as well as a potential patient population of more than 3 billion people. Beyond the research advantages, the evolving regulatory environment in Japan, China, South Korea, and other Asian countries also makes these particularly fast growing markets attractive for your products.
The key to success in these regions is for you to connect with the right resources for your specific development and market access programs. Axzons has the local knowledge, experience, and advanced, end-to-end resources in every key emerging market – including Latin America, India, China, and more – to help accelerate your drug development journey from beginning to end, including meeting regulatory requirements and commercializing your products for long-term global success.