60 Day Window for Clinical Trial Approval Official, says George Clinical, a leading Asia-Pacific CRO.

60 Day Window for Clinical Trial Approval Official, says George Clinical, a leading Asia-Pacific CRO.

9 AUGUST, 2018 – (BEIJING) In another positive development in China’s rapidly evolving regulatory environment The China National Drug Administration (CNDA) has introduced a 60-day window for clinical trial approvals, mirroring US FDA protocols. The rules have taken immediate effect. “This new ruling has major implications for sponsors wishing to conduct China-only or multi-centre studies […]

Read More

August 15th, 2018

Significant changes ahead for drug development in China?

Significant changes are ahead for clinical research in China. The Public Consultation Notice for Policies to Encourage Innovation and Reform in Regulation of Drug and Medical Device Clinical Testing was released by the CFDA on 11 May, 2017. These proposed changes herald an exciting new era for drug and device development. If implemented in full, […]

Read More

June 16th, 2017
Thrombolysis will continue to be the mainstay for stroke treatment

Thrombolysis will continue to be the mainstay for acute stroke treatment

Thrombolysis will continue to be the mainstay for acute stroke treatment, despite the recent revolution in neurointerventional clot retrieval. However, as there are ongoing limitations of thrombolysis of bleeding risk and reduced efficacy in large clots – what possible therapeutic advancements can complement or act as an adjuvant to thrombolysis? Neurointervention – effective, but limited […]

Read More

January 2nd, 2017
Regulatory timelines in Asia

Regulatory timelines in the Asia-Pacific

An at-a-glance round-up of the arrangements for clinical trial applications in 10 countries in the region. Australia Australia is unique in that its Human Research Ethics Committees (HRECs) have responsibility for the oversight and ongoing monitoring of trials, including reviews and approvals. The first step is submission of the clinical trial to the HREC for […]

Read More

December 30th, 2016
TGI and GC increase ties with Japan

China-Australia Free Trade Agreement – The Healthcare Opportunity

China is Australia’s largest trading partner – worth $8.8 billion in 2014-2015. China and Australia are also growing partners in science and research and this is an important area for growth in bilateral relations. China is and has been Australia’s key focus for science and research collaboration efforts; generating advances in medical research, biodiversity, net […]

Read More

December 26th, 2016
Regulatory environment in China

China’s dynamism requires a nimble CRO with extensive research networks

China’s meteoric growth over the past twenty years (or so) has seen it go from strength to strength, particularly in the clinical trials sector. As the clinical trial market of the world’s most populous nation (and second largest economy) continues to mature, so does their regulatory requirements. These regulatory adjustments pose a risk to sponsors […]

Read More

December 15th, 2016
Recruitment in a CRT stroke trial

Recruitment in a Cluster Randomized Stroke Trial

Generally, the unit of randomization in a randomized clinical trial (RCT) is the individual participant (the patient). Occasionally, the unit of randomization can be a cluster, such as hospitals, schools, villages, etc. When randomizing large groups, the concept of cluster randomized trials (CRTs) has become increasingly common. Patient clusters are allocated to the intervention arms […]

Read More

December 13th, 2016
Part III China

Part III: China’s Future in Global Clinical Research

Active international collaboration has facilitated the rise of the Asia-Pacific region in global clinical research. In the first two parts of this blog series, we’ve discussed how Japan and South Korea – whose clinical research environments vary significantly from each other – share many common interests in their pursuit for advancing clinical R&D. The open […]

Read More

December 7th, 2016
Part II Insights on CT environment – Sth Korea

Part II: Insights on the Clinical Trial Landscape of South Korea

Japan has taken significant steps in establishing itself as a major player in the global clinical research community, driving the demand for more clinical trials across East Asia as a result. By officially acknowledging and seeking clinical data from the Asia-Pacific region, Japan is facilitating a dialogue with one of the most powerful and capable […]

Read More

December 5th, 2016
Part I Clinical trial environment in China

Part I – The clinical trial landscape of the Asia-Pacific, Japan

On the heels of our recent post on our presence at this week’s DIA Japan 2015, BBK welcomes Philip Gregory, the General Manager of George Clinical – CRO China as our guest contributor. With more than 20 years of experience in pharmaceutical, biotech and medical device marketing, Mr. Gregory has spent over 14 years supporting the […]

Read More

December 3rd, 2016