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 …
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 …
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 …
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 …
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 …
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 …
A feasibility study is a crucial part of the clinical trial planning process. It enables sponsors and contract research organisations (CROs) to identify relevant clinicians …
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 …
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 …
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 …
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.
