Initially developed for the HIV/AIDS crisis in 1992, the US Food and Drug Administration (FDA) established the accelerated approval program to expedite the approval of …

Highlights of a recent panel debate moderated by Christian K Schneider, head of Biopharma Excellence, reviewing emerging approaches to clinical data collection where patient populations …

The highly regulated nature of the pharmaceutical industry means that organisations within this sector are no strangers to the requirement to abide by the various …

Amplexor asked some of its closest partners for their views on the most important developments in Life Sciences regulatory operations in 2022, and for their …

Biopharmaceutical companies are now at an important inflexion point. Most have completed their modernisation of the Regulatory function globally, bringing improvements to efficiency, according to …

Despite the recent shift to hybrid and decentralised clinical trials (DCT), low enrolment, poor retention, and outdated processes are still holding research back. But it’s …

Unless we create a new rule book with user experience at the forefront, operational excellence will remain a distant dream. Traditional industries are regularly disrupted …

As biotechnology and pharmaceutical companies seek innovative solutions to expedite their timelines, efficient management of a clinical trial starts with strategic planning. Submission of an …

The clinical trial industry is developing rapidly in Malaysia. Since 2012 there have been more than 2000 clinical trials across different Therapeutic Areas, hence promoting …

The imperative to obtain a diverse body of clinical trial participants has been stressed in public statements for decades, including formal promotion by the U.S. …