Presenting at this year’s Accelerating Clinical Trials in Asia 2017, Novotech CRO Executive Director Dr Yooni Kim presented an overview of recent regulatory change in Asia and discussed its resulting impact on clinical trial management and patient recruitment.
“Competition within Asia’s clinical trial industry is noticeably intensifying. Governments are recognising the economic benefit and positive healthcare impact a robust clinical trial industry can have, and are making moves to further support their own domestic industries,” said Novotech Executive Director of Asia Operations Dr Yooni Kim, “Collectively, they are focusing on simplifying regulatory approval processes; increasing government support and clinical trial industry infrastructure; and promoting the potential healthcare benefits of clinical trial participation to their citizens.”
“Sponsors consider three key elements when considering a country for a clinical trial:
- Clinical trial speed: A combination of regulatory approval, ethics review and patient recruitment timelines.
- Data quality: This includes confidence in the data being produced, quality of the clinical trial infrastructure being used, and in the Key Opinion Leader (KOL) directing the clinical trial.
- Overall cost: Including the cost of standard of care and the availability of government R&D incentives.
“Over the past year, countries within the Asia Pacific region have worked hard to address their specific clinical trial industry challenges; but despite these positive efforts, it is important sponsors appreciate regulatory regimes are heterogeneous. Institutional Review Board approvals, regulatory, import licensing and contract negotiations are undertaken simultaneously in some countries and sequentially in others,” explained Dr Kim, “This is where working with a regional CRO can make all the difference to the success of a clinical trial. With their country-specific experience and strong relationships with local KOLs and institutions, they will guide you through each country’s unique and changing regulatory environment, ensuring time is not wasted.”
“With 13 offices in 11 countries throughout in the Asia Pacific, Novotech actively works with each country’s regulatory authorities and key clinical trial centres to improve approval processes and timelines. Novotech is committed in providing our clients with access to the untapped benefits available in the Asia Pacific region,” Dr Kim added.
As the leading Asia Pacific CRO, Novotech continues to grow in the region with the:
- Launch of a site monitoring (SMO) business to support clinical trial activity in South Korea and Taiwan
- Signing of two MOUs with leading clinical trial networks in South Korea
- Launch of a central labs service in Australia
For more information about the untapped clinical trial benefits available in Asia, download a free copy of the Frost & Sullivan white papers, ‘Asia: Preferred Destination for Clinical Trials’, or feel free to contact us.
About Novotech - www.novotech-cro.com
Headquartered in Sydney, Novotech is internationally recognised as the leading regional full-service contract research organisation (CRO). With a focus on clinical monitoring, 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, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence included running clinical trials in all key regional markets. Novotech also has worldwide reach through the company's network of strategic partners.
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