Novotech CRO sees 26% growth in Asia trial activity from biotechs, but still plenty of capacity
As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.
China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.
Australia has long been a popular location for international biotechs with its 43.5% rebate on clinical trial costs, as well as quality, and meeting timelines.
Novotech, which has been in the region for more than 2 decades, has experienced teams across 11 Asia-Pacific countries to accommodate the increased demand.
The company says the growth is driven by an increase in sponsors requiring larger studies, making the Asia-Pacific region a key location to both extend global trials and to conduct full clinical trials.
US Support Offices
To support this research shift to the Asia-Pacific, Novotech has established teams of Asia region clinical trial experts at their offices in San Francisco, Boston and Washington DC. This way biotechs can meet Novotech teams locally to plan their trials roll-out, which are then managed by the Novotech offices in the Asia-Pacific.
In addition, the Novotech office in D.C is focused on regulatory affairs.
The Asia-Pacific trials growth trend is backed by findings by GlobalData:
The estimated number of clinical trial sites opened by biotech companies in the Asia-Pacific has been increasing by 26% each year on average over the last two years compared to 9.5% in the rest of the world.
Warnings and risks
However, Novotech cautioned that it was a complex process running trials in the region with cultural and regulatory challenges, and the need for strong relationships and partnerships to access the best PIs, KOLs and the millions of patients via advanced hospital database systems.
Novotech CEO Dr John Moller said:
“A CRO without the experience and relationships in the region puts at risk the benefits of trials in Asia including up to 20% cost savings for pivotal studies and attractive timelines, as well as impacting quality.”
Novotech has signed over 20 formal partnerships with key hospitals in South Korea, Greater China, Thailand, Singapore, India and Malaysia to facilitate the project management of clinical trials for its biotech clients.
“Novotech’s in-country relationships enable a more comprehensive understanding of local regulatory changes, access to leading PIs, strong site connections, and productive patient populations to deliver success for our clients within timelines and budgets – especially as clinical trials are becoming larger and more complex,” said Dr Moller.
Dr Moller said many clients are surprised to learn of the caliber of Asia-Pacific Investigators.
Recent research for Novotech has found that there are over 43,000 active Principal Investigators across the 11 leading Asia-Pacific markets, which is close to North America, but with a lower trial density limiting the risk of competing trials.
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Established in 1996 and headquartered in Sydney, Novotech is internationally recognised as the leading regional full-service contract research organisation (CRO). Novotech has been instrumental in the success of hundreds of Phase I – IV clinical trials in the Asia Pacific region.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence includes running clinical trials in all key regional markets. Novotech also has worldwide reach through the company’s network of strategic partners.