19 July 2017, Sydney, Australia and Seoul, Korea: Asia Pacific specialist CRO Novotech announced today it has expanded its business offering to include clinical trial site management organisation (SMO) services with the launch of Novotech SMO Korea Co. Limited in South Korea.
Novotech’s new business will train and provide clinical research coordinators (CRCs); as well as site management associates (SMAs) who will be able to support clinical trial principal investigators with site feasibility, patient recruitment and IRB support, based on Novotech’s SMO experience.
Site management organisation (SMO) collaboration between principal investigators and sponsors is common within the US, EU and Japan. Novotech launched its new SMO business in response to unmet industry need in South Korea. South Korea’s SMO industry is still quite young, with the legal foundations of the business model only being established through a revision in its Good Clinical Practice Guidelines in October 2016. Novotech also has several years of experience undertaking SMO projects in Taiwan.
Commenting on the new SMO offering Novotech CEO Dr. John Moller said, “South Korea is without a doubt a global leader within the clinical trials industry and we look forward to providing high quality SMO services to meet growing demand from South Korea.”
“With the launch of our new SMO business, Novotech is committed to providing our clients with high quality clinical trial support across all levels, from start to finish. As the demand for education and quality assurance for clinical trial staff grows, Novotech is not only able to offer clinical service as a CRO; we are now also able to provide a comprehensive range of specialized CRC and SMA services. Through our SMO operations, we will provide a strong supply of CRC and SMA personnel to fulfil South Korea’s industry needs,” said Novotech Executive Director for Asia Operations Dr. Yooni Kim.
A site management organisation (SMO) is an organization which provides clinical trial-related services to clinical trial institutions and principle investigators.
 Enforcement Rule of Medicinal Product Safety [Attachment table 4] Good Clinical Practice Guidelines (amendments 28 Oct 2016) 의약품 등의 안전에 관한 규칙 [별표 4] 의약품 임상시험 관리기준 (개정 2016.10.28) - http://www.law.go.kr/법령/의약품등의안전에관한규칙