Nearly half of all clinical trials in the world are now conducted in the Asia Pacific (APAC) region, reflecting the area’s increasing importance in the field of medical research and drug development.
This development is a result of APAC’s diverse patient populations, cost-effectiveness, increasingly supportive government policies and incentives, and also increasing acceptance of data from APAC clinical trials by major regulatory bodies like the U.S. FDA and EMA.
For medical, biotech, and pharmaceutical companies looking to conduct trials in this promising region, partnering with an experienced clinical research organisation (CRO) is essential. CROs play a crucial role in the success of clinical trials in APAC by handling the planning, execution, and management of every stage of the research process.
In this article, we explore how CRO partnerships are imperative to clinical trials in APAC, making the process faster and more streamlined while maintaining the highest standards in compliance and operations.
What are Clinical Research Organisations (CROs)?
Clinical research organisations (CROs) are companies that partner with the pharmaceutical, biotechnology, and medical device industries to provide clinical trial and drug development services.
A CRO is responsible for effectively planning, executing, and managing clinical research trials from beginning to end. Acting as the primary liaison between the trial sponsor and various stakeholders, the CRO coordinates communication with ethics and compliance committees, regulatory authorities in different countries or jurisdictions, vendors, medical professionals, trial subjects, and research coordinators throughout the trial.
Depending on its scope of services, a CRO will typically carry out the following functions during a clinical trial:
Clinical trial design and monitoring
Patient recruitment
Site selection
Regulatory compliance
Data collection and documentation
Quality checks and audits
Logistical planning
Post-research follow-up
Project management
How Regional CRO Partnerships Can Speed Up Clinical Trials in APAC
With their extensive experience, local expertise and connections, regional clinical research organisations can facilitate smoother and quicker implementation of research trials across Asia without compromising the quality of results or integrity of methods.
Faster Clinical Trial Approvals With Regulatory Expertise
Each APAC country has its own set of regulations, local policies, and authorities governing the execution of clinical research trials. These range from the Pharmaceutical and Medical Devices Agency (PMDA) in Japan to Singapore’s Health Sciences Authority (HSA).
Regional CROs are well-versed in country-specific requirements for clinical trials in APAC and often have established connections with regional regulatory bodies. They will coordinate with ethics committees and Institutional Review Boards (IRBs) on behalf of research sponsors to ensure the trial meets all legal and ethical standards.
This enables CROs to streamline registration and reduce approval timelines by weeks or even months, helping sponsors avoid common administrative bottlenecks.
Reducing Delays in Patient Recruitment and Retention
A key factor contributing to APAC’s appeal as a location for clinical research is the access to a large and diverse patient population. However, attracting and retaining suitable trial subjects can be challenging and time-consuming if not managed properly.
CROs expedite this process by identifying high-enrolment locations in a particular country and partnering with hospitals or other medical facilities with previous experience in clinical trial recruitment.
Where language and cultural barriers pose a challenge, CROs can assist trial sponsors by engaging with local communities and communicating with the patient population. They can offer multilingual support, and provide translated learning materials to ensure participants fully understand the trial and their roles within it.
Rapid Site Setup and Efficient Management for Clinical Trials
Choosing the right site for a clinical trial can be a lengthy and laborious process. CROs with local expertise play a pivotal role at this stage for APAC trials thanks to their familiarity with the local area and experience in managing past trials.
By partnering with the right CRO, sponsors can quickly identify and establish ideal trial sites with the necessary infrastructure, including clinical facilities, IT and data management systems, patient accommodation, and other essential resources.
CROs are also able to provide comprehensive training for research coordinators and assistants, ensuring that they adhere to local and international research standards and protocols.
Moreover, CROs play a crucial role in preventing disruptions and inefficiencies from hindering clinical trial progress. They achieve this through continuous quality checks and audits, ensuring that trial sites remain compliant with regulatory requirements and maintain the highest standards of operation.
Experienced Talent Pool for Faster Trial Execution
Regional CROs speed up clinical trials in APAC progress by providing a pool of skilled clinical research personnel from the local workforce.
Access to experienced, local talent minimises delays associated with sourcing and training international staff. Local research associates and personnel also bring valuable regional expertise, including familiarity with the population, regulatory landscape, and cultural nuances. This saves time that would otherwise be spent on helping clinical trial staff adapt to the location or learn the language.
Partnering with a CRO enables trial sponsors to utilize local clinical research associates (CRAs) for on-site monitoring and risk management, biostatisticians and data managers for robust data collection and statistical analyses, and regulatory affairs specialists who will navigate compliance, ethics, and documentation requirements.
Cost-Efficiency and Operational Agility
Regional CROs operate with a strong understanding of the APAC market and are highly agile in responding to the unique challenges of the region. Their on-the-ground teams have a clear understanding of local regulations, cultural dynamics, and healthcare practices, enabling them to adapt quickly to site-specific needs or unexpected hurdles.
For example, they can efficiently manage protocol deviations or regulatory amendments without the delays that can occur when working with less familiar global CROs.
Regional CROs are also equipped to manage trials of varying scales, from small niche studies to large multi-site, multi-country trials. Their operational models are designed to scale up or down across multiple countries based on the needs of the sponsor, ensuring cost-efficiency at every stage. This flexibility is particularly valuable in APAC, where trial complexity can vary significantly between countries.
Advanced Technology and Time-Saving Digital Solutions
CROs leverage cutting-edge technology to enhance efficiency, improve data accuracy, and accelerate clinical trial timelines.
One of the most innovative developments in clinical trial technology is the adoption of Electronic Data Capture (EDC), which allows for remote monitoring and data collection through Web app interfaces, interactive voice systems, and more.
Platforms like EDC streamline trial data collection by eliminating the inefficiencies of manual entry and reducing the risk of human error. All trial data is collected and analysed accurately in real time, and can be reviewed remotely by stakeholders and regulatory bodies without the need for repeated site visits.
Partnering with CROs also allows trial sponsors to access risk-based monitoring (RBM) and predictive analytics capabilities. Using these technologies, CROs can identify and mitigate potential disruptions before they escalate and cause costly delays.
Enhance Trial Efficiency and Speed With a Trusted Regional CRO Partnership in APAC
As the APAC region continues to establish its position as a leader in international clinical research, the role of CROs is more vital than ever. By reducing regulatory setbacks, accelerating patient recruitment, and leveraging advanced technology, CROs significantly cut down clinical trial timelines and help sponsors bring life-saving treatments to market faster.
And by combining local expertise with swift, adaptive management, regional CRO partnerships in APAC enable sponsors to conduct trials efficiently, accelerate timelines, and maximize their return on investment—all while maintaining high-quality standards.
At ClinActis, we offer tailored solutions for pharmaceutical and biotech companies looking to conduct clinical trials across APAC. With our expertise in regional regulatory navigation, site management, clinical staffing, and data management, ClinActis helps streamline clinical trial operations and enhance the outcomes of conducting research in APAC.
To learn more about how ClinActis can support your efforts in the region, explore our full range of services here.
Comments