All Clinical Research articles
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Industry newsFDA launches Operation TrialBlazer to accelerate US clinical research
The US Food and Drug Administration (FDA) has announced plans to revitalise clinical research in the USA, as part of a US Department of Health and Human Services (HHS) initiative titled ‘Operation TrialBlazer’. The FDA has proposed multiple actions to achieve this aim, targeting both early- and late-stage ...
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Industry newsMHRA points to clinical trial growth and faster assessment routes
This industry news update shares how clinical trials have grown over the past year and new regulations coming into effect.
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JournalPrescribing efficiency: Using generative artificial intelligence for pharmacovigilance
Pharmacovigilance stands as a cornerstone of patient safety but the processes can be arduous. This article explores how generative AI can optimise workflows, reduce reporting burdens and improve timeliness.
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FocusA regulatory lens on an industry imperative: Diversity in clinical research
Although clinical research is evolving alongside new technological advances, the inclusion of diverse populations within clinical trials has been slow. Regulatory professionals are essential stakeholders in the quest for ensuring inclusivity of these groups…
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JournalOn the path to adoption of decentralised clinical trials
Decentralised clinical trials (DCTs) offer great potential to improve the clinical trial paradigm, bringing more diversity and less burden to the participants we serve. COVID-19 has driven DCTs, offering greater flexibility to clinical trial patients. More needs to be done to make DCTs a standard option.
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FocusClinical Trial Information System: overview, opportunities and challenges
The implementation of the Clinical Trial Information System (CTIS), from 31 January 2022, will facilitate the day-to-day business of sponsors of clinical trials by harmonising submission and maintenance of trial applications, assessment and supervision of trials, while promoting patient safety and transparency…