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Volume 16 Issue 2
 
Volume 15 Issue 1

The Role of Confirmatory Trials After Accelerated Approval

Initially developed for the HIV/AIDS crisis in 1992, the US Food and Drug Administration (FDA) established the accelerated approval program to expedite the approval ...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

Rethinking Statistical Significance in a Rare
Disease Context

Highlights of a recent panel debate moderated by Christian K Schneider, head of Biopharma Excellence, reviewing emerging approaches to clinical data collection where...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

Data Protection and Clinical Trial

The highly regulated nature of the pharmaceutical industry means that organisations within this sector are no strangers to the requirement to abide by the various st...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

The Year Ahead for Life Sciences Regulatory
Operations

Amplexor asked some of its closest partners for their views on the most important developments in Life Sciences regulatory operations in 2022, and for their predicti...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

Beyond modernisation– Unlocking the Value
of Regulatory Information Management

Biopharmaceutical companies are now at an important inflexion point. Most have completed their modernisation of the Regulatory function globally, bringing improvemen...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

Next-level Clinical Trial Technology Can
Avoid Dropouts and Accelerate Drug
Development

Despite the recent shift to hybrid and decentralised clinical trials (DCT), low enrolment, poor retention, and outdated processes are still holding research back. Bu...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

Digital Clinical Trials: Time to Throw Out the
Old Rule Book

Unless we create a new rule book with user experience at the forefront, operational excellence will remain a distant dream. Traditional industries are regularly d...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

Developing a Pre-IND Packing Strategy to
Expedite Clinical Trial Timelines

As biotechnology and pharmaceutical companies seek innovative solutions to expedite their timelines, efficient management of a clinical trial starts with strategic p...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

CRM Study Coordinators – Making a Difference in Clinical Trial Conduct in Malaysia

The clinical trial industry is developing rapidly in Malaysia. Since 2012 there have been more than 2000 clinical trials across different Therapeutic Areas, hence pr...
29 March 2023 Volume 15 Issue 1
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Volume 15 Issue 1

Who Cares About Diversity in Clinical Trials?

The imperative to obtain a diverse body of clinical trial participants has been stressed in public statements for decades, including formal promotion by the U.S. Nat...
29 March 2023 Volume 15 Issue 1
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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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