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Volume 14 Issue 5

How the FDA Sped Up Cancer Product Development and Reviews During a Global Pandemic

Amid the ongoing COVID-19 public health emergency, the US Food and Drug Administration (FDA) has emphasised the importance of caring for patients with established con...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

How to Streamline a Complex Process: The Value Add of Experienced Medical Writers for Oncology Dossiers

Oncology is one of the most common areas of drug development in the pharmaceutical industry. In 2020, the majority of new drugs approved by the FDA were cancer treatm...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

Achieving Simultaneous New Drug Document Submission for the FDA and EMA

International Conference on Harmonization (ICH) guidance makes it feasible to construct a new drug submission dossier that can be used for applications to multiple co...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

Turning Pharmacovigilance into a Strategic Advantage

Safety science complexity is on the rise as the volume of safety data explodes (case volumes are growing at a pace of 15 to 20% per year),1 regulatory scrutiny contin...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

Why Do We Need Patient Diversity in Clinical Trials?

Ensuring Drug Safety, First and Foremost, Even Ahead of Drug Efficacy In the commercialisation of new medications, the paramount legal responsibilities of the pharma...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

Improving Health Literacy to Transform Clinical Trials

The healthcare industry struggles with resolving fundamental patient communication challenges. Approximately 50% of adults cannot read at a high school level and 88% ...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

Asia’s Clinical Trial Growth – Industry Developments and Challenges

Clinical trials within Asia are on the rise again, however, the effects of the COVID-19 pandemic continue to have a significant impact on the industry. While the numb...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

Optimising Trials Assessing Cognitive Post-Acute Sequelae of SARS-CoV-2 Infection (PASC-Cog)

Long COVID-19 syndrome has recently been recognised as a complex chronic clinical entity in subjects who have experienced SARS-CoV-2 infection. It is currently define...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

How Digital Health Can Reshape Pharma’s Hole in Healthcare

In light of the proposed shift to value-based healthcare, Gérard Klop and Marcos Gallego Llorente of Vintura set out their vision for how pharma can grow its role in ...
4 October 2022 Volume 14 Issue 5
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Volume 14 Issue 5

PCI clinicalSMART™: A SMART Solution to Clinical Supply Management

With the number of registered clinical trials increasing significantly each year, it’s not surprising to learn that the clinical trials supply and logistics market is...
4 October 2022 Volume 14 Issue 5
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Journal for Clinical Studies

Journal For Clinical Studies has a distinguished editorial advisory board providing the best guidelines for global clinical trials. Your resource for Multisite Studies and emerging markets.

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