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Despite the recent shift to hybrid and decentralised clinical trials (DCT), low enrolment, poor retention, and outdated processes are still holding research back.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