The contract research organization (CRO) has 10 strategic collaborations with hospitals and research institutions in the area and increased its clinical staff to 41 over the last 12 months.
“Novotech staff in South Korea has grown by about 40% compared with last year, which represents one of the fastest growth for a CRO in the country, and reflect the increase clinical trial demand in the country,” said Yooni Kim, Novotech executive director, Asia operations.
According to the company – which now has 41 clinical staff members at its center in South Korea – recent regulatory changes have facilitated study start-up, with the Ministry of Food and Drug Safety (MFDS) and ethics committee (EC) approvals now taking just over two months on average.
Additionally, Kim said the volume of sites opened by western small- and medium-sized biotech companies in South Korea has increased by 17% over the last 12 months – “showing a greater interest from North American and European companies.”
“The region is changing rapidly and the outcome of clinical trials strongly relies on how the study in managed operationally by the CRO and which investigators are involved in the trial,” Kim told us.
According to a report published by Frost & Sullivan, the Asia Pacific CRO market is estimated to grow at a compound annual growth rate (CAGR) of 19.9%in 2020, as opposed a 10.4% CAGR expected in North America.
The report cited three key factors make Asia a preferred destination for clinical trials: speed, worldwide data acceptability, and cost-effectiveness.
Novotech has been present in South Korea since 2007 and completed 10 MFDS inspections with no major findings. It has 11 offices across the Asia-Pacific region.
The company in April of last year signed a memorandum of understanding (MOU) with the Asan Medical Center (AMC) Clinical Trial Center, which it has worked with since opening its operation in the country. The MOU formalized the company’s relationship with the center and its principal investigators.
