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…
The purpose of clinical trials is to find answers to a research question by generating data to prove or disprove…
Oncology trials have always relied on tumour response to gauge the efficacy of the drugs they assess. The traditional primary…
How treatments affect aspects of life that are most important to patients is a priority for the US Food and…
Preparing for a regulatory inspection can be daunting – but it doesn’t have to be. The stress of an inspection…
The past few years have witnessed a burgeoning global interest in the development of therapies related to cannabis (Cannabis sativa…
The European Union (EU) Medical Device Regulation (MDR) is the biggest challenge to the medical device industry in over 20…
A feasibility study is a crucial part of the clinical trial planning process. It enables sponsors and contract research organisations…
In advance of a prospective pivotal biosimilar safety and efficacy trial, researchers reviewing the data from the Phase III clinical…
January 2018 marked the centennial of the 1918 influenza worldwide pandemic, which served as a stark reminder that the need…
The relative merits of the functional service provision (FSP) and full service (FS) outsourcing models have been debated repeatedly over…