ClinActis: Leading the Way in Clinical Trials Across APAC
About ClinActis
ClinActis is a regional, full-service Contract Research Organization (CRO), which has been dedicated to advancing clinical research across the Asia-Pacific (APAC) region since 2009. With a strong commitment to international quality standards and local expertise in APAC, we provide comprehensive clinical trial services tailored to the unique needs of our clients, and to the complex requirements of the APAC region.
Our operations span key countries and territories across the APAC region, including South Korea, China, Taiwan, Hong Kong, Malaysia, Singapore, Thailand, the Philippines, and Australia/New Zealand. We specialize in delivering high-quality, efficient, and culturally sensitive clinical trials that meet international standards.
Overview of Services
At ClinActis, we offer a full suite of clinical trial services, including:
Our team of experts ensures that every aspect of the trial process is meticulously planned and executed, providing our clients with reliable and actionable results for clinical trials conducted in APAC.?
The ClinActis Advantage
Core Value Proposition
Our team’s in-depth local expertise within each APAC country is combined with extensive experience in conducting and supporting international trials. This local expertise and global experience enable us to ensure trials are conducted efficiently and in compliance with local regulations and clinical practices, while also adhering to stringent international quality standards required by regulatory agencies like the FDA and EMA. This unique blend of local insight and global proficiency allows us to deliver outstanding results for our clients in the most efficient and cost-effective manner possible.
How We Work
ClinActis has the experience and capabilities to support all phases of clinical trials. We are fully equipped to conduct single-region, early phase trials in APAC, providing robust data that can be used for later stage regulatory submissions to the FDA or EMA. And our extensive experience in supporting late phase clinical trials is enhanced through strategic partnerships with CROs from other regions, ensuring seamless integration and execution on multi-region and global trials. This makes ClinActis an ideal partner for collaborative clinical trial strategies where more than regional specialist CROs are preferred.
Elevating Clinical Project Management at ClinActis
In the diverse landscape of the Asia-Pacific (APAC) region, the importance of effective local and regional clinical project management is often underestimated. With its intricate tapestry of regulations, varied healthcare systems, languages and cultures, APAC clinical trials present unique challenges that require a combination of global standards and deep local insight.
At ClinActis, we excel by seamlessly integrating international project management standards with a profound understanding of local nuances. Our project managers are not only globally trained with backgrounds in pharma, biotech, and CROs outside the Asia Pacific, but also possess an unparalleled breadth of knowledge about APAC's regulatory environments, site networks, and local clinical practices. This dual expertise enables us to anticipate and plan for contingencies efficiently, ensuring smooth operations on both global and local fronts.
Our agility in adapting global standards to fit local practices sets us apart, allowing us to navigate the complexities of APAC with precision and insight and deliver exceptional results for our clients. We focus on proactive planning rather than wasting time troubleshooting, keeping projects on track (and on budget) from the start.
Advantages of Conducting Clinical Trials in APAC
The Asia-Pacific region offers numerous advantages for conducting clinical trials, making it an increasingly attractive destination for pharmaceutical and biotech companies.
Diverse Patient Populations
With over 60% of the world's population residing in APAC, access to a diverse participant pool is unparalleled, providing a rich demographic mix for more representative clinical studies, offering diverse genetic, environmental, and lifestyle variations. This diversity enables comprehensive studies that can yield globally relevant data and insights, enhancing the generalizability of clinical trial results.
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Cost-Effectiveness
Conducting clinical trials in APAC can be 30-40% more cost-effective compared to Western countries. Lower operational costs, coupled with access to large patient populations, provide an attractive value proposition for sponsors.
Data Accepted by Major Regulatory Bodies
Clinical data from the APAC region is increasingly being accepted by major regulatory bodies like the FDA and EMA. In fact, since the late 1990s, clinical trials in Asia have been predominantly for FDA/EMA submissions. This underscores the region's ability to produce high-quality data that meets the stringent requirements of leading regulatory authorities.
Advanced Healthcare Infrastructure
Countries like South Korea, Singapore, Australia, and New Zealand boast state-of-the-art healthcare facilities and technology. These nations are equipped with advanced research centers and skilled medical professionals, supporting complex and innovative clinical trials.
Strict and Efficient Regulatory Pathways
Many APAC countries have streamlined regulatory processes, allowing for faster trial initiation and approval. Agencies like South Korea’s Ministry of Food and Drug Safety (MFDS) and Australia’s Therapeutic Goods Administration (TGA) provide clear guidance and efficient review timelines. And countries like Singapore and Malaysia, ranking high in regulatory efficiency, ensuring smooth approval processes. ICH GCP standards are accepted as the primary standard in most countries, ensuring high compliance and quality.
Strong Government Support
Governments across the region actively support clinical research through funding, policy initiatives, and public-private partnerships. This environment fosters innovation and collaboration, with countries like China and India investing heavily in research and development.
Good Clinical Infrastructure
APAC boasts top-notch clinical research facilities and infrastructure, with countries like South Korea and Australia leading in healthcare quality. Malaysia and Thailand also stand out, offering a good balance between high-quality healthcare and competitive costs.
Make ClinActis Your APAC CRO Partner
ClinActis is uniquely positioned to leverage the advantages of conducting clinical trials in APAC, offering clients unparalleled expertise, experience and support in conducting clinical trials across the region. Our commitment to excellence, combined with our deep regional knowledge and global quality standards, makes us the ideal partner for advancing your clinical development program in the Asia Pacific region
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