Current Edition

Ensuring Appropriate and Reliable Data is Collected for Conclusive First-in-human/Phase I Trials
Volume 11 Issue 6

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

The purpose of clinical trials is to find answers to a research question by generating data to prove or disprove a hypothesis. By their very nature, first-in-human (...
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The Changing Face of Oncology Endpoint Monitoring
Volume 11 Issue 6

The Changing Face of Oncology Endpoint Monitoring

Oncology trials have always relied on tumour response to gauge the efficacy of the drugs they assess. The traditional primary endpoint for an oncology trial is tumou...
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Clinically Important Endpoints to Measure Heart Failure
Volume 11 Issue 6

Clinically Important Endpoints to Measure Heart Failure

How treatments affect aspects of life that are most important to patients is a priority for the US Food and Drug Administration (FDA) as it seeks ways to facilitate ...
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Volume 11 Issue 6

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

Preparing for a regulatory inspection can be daunting – but it doesn’t have to be. The stress of an inspection can be lessened by building inspection-readiness pract...
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Addressing Regulatory Challenges in Clinical Trials of Cannabis-Related Drug Products
Volume 11 Issue 6

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

The past few years have witnessed a burgeoning global interest in the development of therapies related to cannabis (Cannabis sativa L.) and its components, including...
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The MDR: The Clock is Ticking
Volume 11 Issue 6

The MDR: The Clock is Ticking

The European Union (EU) Medical Device Regulation (MDR) is the biggest challenge to the medical device industry in over 20 years. With the new regulations come more ...
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Attracting Clinical Research to Malaysia with a Centralised Feasibility Platform
Volume 11 Issue 6

Attracting Clinical Research to Malaysia with a Centralised Feasibility Platform

A feasibility study is a crucial part of the clinical trial planning process. It enables sponsors and contract research organisations (CROs) to identify relevant cli...
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Subgroups, Study Design, and the Impact of the Biosimilar Extension Rule
Volume 11 Issue 6

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

In advance of a prospective pivotal biosimilar safety and efficacy trial, researchers reviewing the data from the Phase III clinical trial of the reference molecule ...
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The Need to Finally Get it Right with Universal Influenza Vaccines
Volume 11 Issue 6

The Need to Finally Get it Right with Universal Influenza Vaccines

January 2018 marked the centennial of the 1918 influenza worldwide pandemic, which served as a stark reminder that the need for a universal influenza vaccine is para...
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Volume 11 Issue 6

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

The relative merits of the functional service provision (FSP) and full service (FS) outsourcing models have been debated repeatedly over at least the last ten years....
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