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…
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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…
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…
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…
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…
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…
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…
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…
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…
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…