Good Clinical Practice (GCP) focuses on data quality and integrity. Clinical trial sponsors must demonstrate strict oversight of studies to ensure proper conduct, safety of …

As life sciences companies take action to speed up study execution, there is a significant opportunity to make clinical research processes more efficient. Rik van …

Early-phase clinical trials, known as human pharmacology studies, start principally with the aim of collecting information on the safety and tolerability of the drug product. …

It is extremely rare for CROs to move seamlessly through an entire clinical trial without encountering some problems or hurdles. But what you don’t want …

In February 2020, the thirteenth international Rare Disease Day was held, where hundreds of patient organisations from countries and regions all over the world organised …

During the last eight years, the US Food and Drug Administration (FDA) has been increasingly focused on realising a vision—to incorporate patient input in drug …

There is a growing movement within the industry to focus on patientcentricity in clinical trials. The FDA and EMA have introduced requirements to include patient …

Today, the vast majority of drugs available for patients in the United States are generics that have gone through a rigorous system of evaluation supervised …

As delays in getting clinical trials up and running have financial implications, pharmaceutical companies and contract research organisations (CROs) are looking at ways to accelerate …

The pharmaceutical industry has a problem; clinical trials are failing to recruit and retain the required number of patients at an alarming rate. The statistics …