Drug Discovery World
FEBRUARY 8, 2023
To make meaningful progress on diverse participation in clinical trials, we need meaningful collaboration with regulators, patients, academia, other biopharma companies and the wider healthcare ecosystem so that together we can achieve a shared goal of better health outcomes for all.”
Quanticate
AUGUST 19, 2024
Understanding and navigating the regulations surrounding audit trail review is essential for all CROs, Biotech’s and Pharma’s to ensure that compliance is maintained, and that auditors and regulators can be reassured that the clinical data meets all the necessary standards.
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Drug Discovery World
MARCH 23, 2023
A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.”
Drug Discovery World
DECEMBER 18, 2023
Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.
Drug Discovery World
OCTOBER 19, 2022
Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+ Dr Olena Karpenko.
Advarra
AUGUST 8, 2024
Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.
Drug Discovery World
OCTOBER 16, 2023
Dr June Raine, MHRA Chief Executive, said: “Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”
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