Tag: APAC

Clinical Research: Phase 1 - Phase 4

7 Factors Fueling the Growth of Oncology Trials in Asia-Pacific

Oncology clinical trial activity in the Asia-Pacific (APAC) region has been robust over the past decade, increasing 138 percent from 2010 to 2020.1 In the past, most studies conducted in APAC countries were later studies, but there has recently been an uptick in the number of phase 1 trials. This bustling activity, in combination with...

Clinical Research: Phase 1 - Phase 4

Conducting Successful Oncology Trials in the Asia-Pacific Region

The Asia-Pacific (APAC) region now ranks first in the world for total number of active oncology clinical trials, with China alone accounting for more than half of those studies.1 To take advantage of the potential benefits of conducting clinical research in APAC countries, sponsors need to understand the nuances of designing and operationalizing studies in...

Clinical Research: Phase 1 - Phase 4

Making the Asia-Pacific Region a Destination of Choice for Oncology Clinical Trials

Introduction Over the past decade, the Asia-Pacific (APAC) region has seen the most robust growth in oncology clinical trial activity, with a 138 percent increase over the period from 2010 to 2020. In fact, APAC now ranks first in the world for total number of ongoing oncology clinical trials, with China accounting for more than...

Clinical Research: Phase 1 - Phase 4

Key Changes in the Revised EMA Guidance on Clinical Trials During COVID

In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent...

Medical and Regulatory Affairs

Advancing Patient Healthcare: Clarifying the 2019 Changes in India’s Drug and Clinical Trial Rules

In 2019, only 1.2 percent of global clinical studies included India, even though it’s estimated that the country bears 20 percent of the global disease burden.1 One reason for the slow growth of clinical research in India has been the country’s stringent regulatory requirements. The Ministry of Health and Family Welfare, responsible for all health...

Clinical Research: Phase 1 - Phase 4

Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research

Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of...

Medical and Regulatory Affairs

5 Reasons to Consider APAC for Clinical Trials

Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. In fact, the number of clinical trials in...

Premier Research Asia-Pacific Expansion Helps Biotech Advance Life-Changing Therapies

DURHAM, N.C., September 27, 2018 — Premier Research, a leading provider of clinical development and consulting services to biotech and specialty pharma companies, has again expanded its presence in the Asia-Pacific region to include South Korea, Singapore, and Taiwan. The moves increase activities in Australia and New Zealand, where Premier has been conducting clinical trials...