Clinical Research Regulations Trials 
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. For example, the regulatory and ethics reviews of clinical trial applications will be integrated.
Drug Discovery World
FEBRUARY 8, 2023
A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases. It also showed that GSK trial enrolment for each condition differed by race and ethnicity.
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Drug Discovery World
OCTOBER 16, 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”
Quanticate
AUGUST 19, 2024
An audit trail is a comprehensive log that records all activities, including modifications, additions, and deletions of data, within a clinical trial. It acts as a chronological record that helps trace the path of data, providing evidence that the data collected was performed in accordance with the protocol and regulatory standards.
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.
PPD
FEBRUARY 19, 2024
The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.
ProRelix Research
JUNE 27, 2024
In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.
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