Since the onset of the COVID-19 public health emergency, the US Food and Drug Administration (FDA) has hosted a weekly “virtual town hall” meeting to …
Until recently sponsors have been able to submit nonclinical and clinical reports without datasets and without fear of rejection. In less than three months, the …
Over the last year, the COVID-19 pandemic has placed healthcare for respiratory medicine firmly in the global spotlight. But even before this, over half a …
Clinical research organisations (CROs) are often buried under massive amounts of data that is difficult to analyse effectively and rapidly. Compounding this problem is that …
As global supply chains strained under the pressure of intense demand and thinning resources created by the COVID-19 pandemic, both the public and private sectors …
Naturally, safety event reporting and pharmacovigilance (PV) should be subject to detailed regulatory scrutiny as evidenced by the Food and Drug Administration (FDA) overseeing the …
The RACE for Children Act provides hope we can accelerate therapies to children, adolescents, and young adults with cancer. As precision medicine increasingly influences paediatric …
The current pace and scale of innovation that we are witnessing within the pharmaceutical industry has not been seen before. The speed at which COVID-19 …
Current and future cancer treatment is expected to be shaped and guided by the use of biomarkers that will guide researchers and physicians at every …
The COVID-19 pandemic put clinical trials firmly in the spotlight. Powered by the urgent need to combat this global threat, clinical trials have been created …
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