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Category Archives: Volume 11 Issue 6

Ensuring Appropriate and Reliable Data is Collected for Conclusive First-in-human/Phase I Trials

Volume 11 Issue 6By flabio513th December 2019Leave a comment

The purpose of clinical trials is to find answers to a research question by generating data to prove or disprove…

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The Changing Face of Oncology Endpoint Monitoring

Volume 11 Issue 6By flabio513th December 2019Leave a comment

Oncology trials have always relied on tumour response to gauge the efficacy of the drugs they assess. The traditional primary…

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Clinically Important Endpoints to Measure Heart Failure

Volume 11 Issue 6By flabio513th December 2019Leave a comment

How treatments affect aspects of life that are most important to patients is a priority for the US Food and…

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How to Prepare for an Inspection and Establish a Culture of Readiness

Volume 11 Issue 6By flabio513th December 2019Leave a comment

Preparing for a regulatory inspection can be daunting – but it doesn’t have to be. The stress of an inspection…

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Addressing Regulatory Challenges in Clinical Trials of Cannabis-Related Drug Products

Volume 11 Issue 6By flabio513th December 2019Leave a comment

The past few years have witnessed a burgeoning global interest in the development of therapies related to cannabis (Cannabis sativa…

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The MDR: The Clock is Ticking

Volume 11 Issue 6By flabio513th December 2019Leave a comment

The European Union (EU) Medical Device Regulation (MDR) is the biggest challenge to the medical device industry in over 20…

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Attracting Clinical Research to Malaysia with a Centralised Feasibility Platform

Volume 11 Issue 6By flabio513th December 2019Leave a comment

A feasibility study is a crucial part of the clinical trial planning process. It enables sponsors and contract research organisations…

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Subgroups, Study Design, and the Impact of the Biosimilar Extension Rule

Volume 11 Issue 6By flabio513th December 2019Leave a comment

In advance of a prospective pivotal biosimilar safety and efficacy trial, researchers reviewing the data from the Phase III clinical…

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The Need to Finally Get it Right with Universal Influenza Vaccines

Volume 11 Issue 6By flabio513th December 2019Leave a comment

January 2018 marked the centennial of the 1918 influenza worldwide pandemic, which served as a stark reminder that the need…

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Functional Service Provision and Full Service Outsourcing Models Have Key Roles to Play in Outsourced Drug Development as Clinical Trials Evolve

Volume 11 Issue 6By flabio513th December 2019Leave a comment

The relative merits of the functional service provision (FSP) and full service (FS) outsourcing models have been debated repeatedly over…

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