Current Edition

Observations on the Regulatory Fast Track to Speed up the Process with Covid-19 Vaccines/Treatment
Volume 12 Issue 3

Observations on the Regulatory Fast Track to Speed up the Process with Covid-19 Vaccines/Treatment

Part of the prophylactic armoury against pandemic disease is a programme of surveillance for emergent pathogens. The current SARSCoV-2 outbreak may have been foresee...
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FDA Focuses on Technology Modernisation Efforts
Volume 12 Issue 3

FDA Focuses on Technology Modernisation Efforts

Under new leadership, the US Food and Drug Administration (FDA) is now focusing efforts on closing the gap between scientific advances and the computing solutions ne...
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Strategies for Continued IRT Success During COVID-19
Volume 12 Issue 3

Strategies for Continued IRT Success During COVID-19

With the rapidly evolving nature of the coronavirus (COVID-19) pandemic, configurability and adaptability are key for IRT systems in order to minimise the impact to ...
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Regulatory Response to Accelerate COVID-19 Drug Development
Volume 12 Issue 3

Regulatory Response to Accelerate COVID-19 Drug Development

The FDA has created a special emergency programme for therapeutics known as the Coronavirus Treatment Acceleration Program (CTAP). This programme attempts to utilise...
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Thinking Outside the Box during the COVID-19 Pandemic
Volume 12 Issue 3

Thinking Outside the Box during the COVID-19 Pandemic

COVID-19 is a new virus with its own characteristics and the human population has showed its naivety. The number of individuals infected with COVID-19 continues to r...
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The Human Side of Oncology Clinical Trials – Stories of True Patient-centricity
Volume 12 Issue 3

The Human Side of Oncology Clinical Trials – Stories of True Patient-centricity

The definition of being truly patient-centric is simply allowing a patient to participate in a clinical trial with minimal disruption to their personal and family li...
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COVID-19 and its Ripple Effect on Clinical Trials
Volume 12 Issue 3

COVID-19 and its Ripple Effect on Clinical Trials

Whilst pandemics are fortunately not common, the global impact of COVID-19 has been profound. At the time of writing, global deaths havereached 420,000 whilst over 7...
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Overcoming Clinical Development Challenges in Oncology with Innovative, Adaptive Trial Design
Volume 12 Issue 3

Overcoming Clinical Development Challenges in Oncology with Innovative, Adaptive Trial Design

Employing Adaptive Approaches to Reach Desired Clinical Objectives The field of oncology is expanding and changing rapidly. With increasing advancements in genomi...
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Blood Pressure Monitoring in Clinical Trials in Obese Subjects
Volume 12 Issue 3

Blood Pressure Monitoring in Clinical Trials in Obese Subjects

The World Health Organization (WHO) classification system for obesity is based on body mass index (BMI). A BMI of 25.0 to 29.9 kg/ m2 is considered overweight, and ≥...
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Serious Adverse Events in Lung Cancer Clinical Trials
Volume 12 Issue 3

Serious Adverse Events in Lung Cancer Clinical Trials

Lung cancer is the leading cause of cancer death – 1.76 million lung cancer deaths occurred worldwide in 2018. More than 80% of patientswere presenting with non-smal...
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