One of Asia-Pacific’s largest regional contract research organizations (CRO) called Novotech, reports that many countries are fast-tracking their COVID-19 clients’ clinical trials with expedited review processes for treatment and vaccine candidates. In fact, Novotech reports another COVID-19 trial was just approved in under 9 days in South Korea—these study launch times are shattering the record books. The South Korean Ministry of Food and Drug Safety (MFDS) announced “Go-expedite”, a program expediting COVID-19 clinical trial review timelines.
Studies launched in record time across Asia
According to a recent press release published in EurekAlert!, the following countries are experiencing rapid acceleration of COVID-19 clinical trial reviews:
· India: review/approval in 10 working days
· Thailand: review/approval in 15 working days
· Malaysia: review/approval in 20 working days
Dr. Yooni Kim, the Executive Director for Asia Operations of Novotech, reports that the regional rapid response represents an important trend vital to research in the region—particularly with the COVID-19 pandemic in the backdrop. Dr. Kim notes, “We are seeing an increased demand for 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.”
Who is Novotech?
Of course, this extraordinary and unprecedented circumstances afford this CRO the opportunity to introduce itself—and it offers Data Bulletins on the situation in Asia posted weekly.
Novotech positions itself as a leading regional full-service contract research organization (CRO) in Asia-Pacific poised to help sponsors with mission-critical Phase I-IV clinical trials. Founded in 1996, they run offices in 11 locations across the region and have inked numerous site partnerships with major health institutions in the region.
Headquartered in Australia, they cover a range of areas from feasibility assessments, ethics committees, and regulatory submissions to data management, statistical analysis, medical monitoring, safety services and central lab services.
With an estimated 650 to 750 employees, they have grown as well via acquisition, such as its 2018 purchase of Clinical Network Services, an Australian-based CRO.
The World has Changed
TrialSite News analysts’ suspect that the world of clinical research has changed for good due to the influence of the global pandemic. The world’s pharmaceutical industry hit a major slowdown due to the pandemic; many, if not most, large clinical sponsors have pivoted and initiated some COVID-19 program—or group within the sponsor supporting the pandemic response.
Record study start up times are now commonplace. TrialSite News has reported on ongoing record-breaking study launches as governments, regulators, sponsors, research centers, and health systems seeking to collaborate and coordinate efforts in an effort to get the pandemic under control. The fact that there are no known vaccines or treatments only intensified the resolve of the global healthcare sector to improve coordination and accelerate timelines.
Although we are not in the “new normal” as of yet, we are beginning to transition out of what was (and still is) the emergency pandemic response. Global clinical sponsors, research sites, and governments will continue to face pressure to come up with treatments and ultimately a vaccine. Consequently, the market for clinical research services is in fact morphing—with the new realities unfolding in real time—and those clinical trial sponsors, vendors (such as CROs), and suppliers of services (e.g. sites) haven’t yet settled into the “new normalcy.” But it surely won’t look like the past, and elements of what we are observing will be incorporated into tomorrow. Regions will be more motivated to court and lure large clinical sponsors to bring more trials moving forward.