Overview of the main points of FDA Informed Consent Guidance released in Aug 2023
FDA have released a final guidance regarding informed consent requirements for clinical trials. This guidance is applicable…
The Major Pitfalls in Clinical Trials Set Up
All of us working in clinical trials set up are acutely aware of the phrase ‘… so…
WHO consultation on clinical trials (2023): Main Points and Analysis
There is an ongoing public consultation by the World Health Organization which aims to update its guidelines…
Oncology Professional Care Conference: Attendee Perspective
I was excited to attend the Oncology Professional Care Conference at the ExCeL Conference Centre in London…
JSMO 2023: Interview with attendee
On 16 to 18th of March 2023 was the Annual Meeting of the Japanese Society of Medical…
Writing Informed Consent for Medical Device Clinical Trials
There is a growing number of medical device clinical trials globally. While they have lots of similarities…
The Undervalued Role of the Clinical Research Associate
Back in the days when all data in the clinical trials was on paper only, pharmaceutical companies…
The Challenges of Conducting Clinical Trials – The Site Perspective
Future of clinical research development depends on so many important factors that collectively still need to be…
Bitesize Regulatory News 20 Oct 2022
Expedited approvals in Japan Japan is one of the leading countries in Asia when it comes to…
Free consultation for products developed in China
Do you have product developed in China? This could be new therapy, medical device, cosmetics, food supplements…