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Volume 13 Issue 4

Virtual Town Halls Provide Timely Support to SARS-CoV-2 Test Developers

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 …

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Volume 13 Issue 4

Data Compliance or Rejection – Are you ready for September 15th?

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 …

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Volume 13 Issue 4

Respiratory Disease Diagnosis and Testing Beyond COVID-19

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 …

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Volume 13 Issue 4

The End of Data Chaos: Modernising Data Infrastructure to Revolutionise Clinical Research

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 …

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Volume 13 Issue 4

What a Global Pandemic Taught Us About the Pharmaceutical Supply Chain

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 …

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Volume 13 Issue 4

Critical Considerations for Clinical Trial Safety Reporting Investments

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 …

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Volume 13 Issue 4

Re-evaluating Paediatric Cancer Endpoints

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 …

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Volume 13 Issue 4

Top 5 Innovations in Clinical Trials that are benefiting the Pharma Industry

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 …

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Volume 13 Issue 4

Recent Advances and Future Challenges Using Biomarkers in Oncology Precision Medicine

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 …

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Volume 13 Issue 4

Expediting Clinical Trials with Cloud-based Metadata Repository and Study Automation Technologies

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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