Novotech COVID-19 clinical trial clients access new Asia-Pacific fast-track processes
A Novotech client’s COVID-19 trial was just approved in under 9 days in South Korea
The Asia-Pacific’s largest specialist biotech CRO Novotech said many countries in the region were now fast-tracking their COVID-19 clients’ clinical trials with expedited review processes for treatment and vaccine candidates.
A Novotech client’s COVID-19 trial was just approved in under 9 days in South Korea.
The South Korean Ministry of Food and Drug Safety (MFDS) has announced “GO-expedite” program where they are expediting the review process for COVID-19 treatment and vaccine trials with specific timelines.
Other countries are also fast-tracking COVID-19 trial reviews including:
- India: review/approval in 10 working days
- Thailand: review/approval in 15 working days
- Malaysia: review/approval in 20 working days
Novotech Executive Director Asia Operations Dr. Yooni Kim said she was pleased to see such a rapid response in the region to support vital research.
“We are seeing an increase in demand from biotechnology sponsors for studies in the Asia-Pacific region because of the speed and quality available here. This expedited review process will further support the race for COVID-19 treatments.”
For the latest updates on the Asia-Pacific clinical trial landscape see our Data Bulletins (updated weekly).
About Novotech – https:/
Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotechnology companies.
Novotech was established in 1996, with offices in 11 locations across the region, and site partnerships with major health institutions.
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, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
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