Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend BIO Korea (May 8-10, 2024) and formally open new clinical operations in Seoul, South Korea.

Avance Clinical CEO, Yvonne Lungershausen said the decision to open clinical operations in Seoul followed increasing demand from later phase US biotechs, as well as CRO partners for access to the region’s scientific excellence and patient populations.

“In addition, feedback from a recent presentation of our GlobalReady drug development solution to more than 75 Korean biotechs and pharmaceutical companies in Seoul showed a real need for Korean clinical operations with a global pathway,” said Lungershausen.

“It’s clear there is a demand for a mid-sized, agile, and responsive CRO with an in-house regulatory affairs team, and a proven track record of swiftly advancing high-quality clinical programs. This makes us an ideal CRO partner for later phase biotechs that are seeking access to significant patient populations,” she said.

“The new South Korean operations also offer a strategic presence for Avance Clinical’s CRO partners conducting multi-regional or global trials.

In addition, Korean biotechs are utilizing our Australian and United States clinical services as they progress their drug development programs,” said Lungershausen.

“Our Avance Clinical teams in APAC, Europe and the United States, offer our biotech clients world-class quality data and seamless geographic expansions to accelerate their drug development programs and position for success.” 

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the MFDS and FDA. In addition, the Therapeutic Goods Administration (TGA) in Australia and FDA recognises data generated in Korea.” 

“Biotechs are looking for a partner that can start fast with high-quality data that is readily accepted by the US FDA and other regulatory agencies. Backed by our in-house global regulatory affairs team, we can navigate biotechs through regulatory complexities with confidence including FDA, EMA, MFDS and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 2,000 highly qualified sites across the globe ensures maximum efficiency and effectiveness for our biotech clients’ trials,” she said.

Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-phase and multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said.