Clinical Guest Contributors
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AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
4/8/2024
The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.
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You’ve Chosen Your Vendor(s), But Have You Thought About Their Oversight?
4/8/2024
Vendor management has become an even more complex task involving multiple stakeholders, and it may often be overlooked, especially in the oversight of subcontracted vendors.
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New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials
4/1/2024
In a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials. The public comment period ends April 15, 2024.
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FDA, MHRA, Health Canada Joint GCP Symposium Focuses On 3 Key Topics
3/27/2024
The FDA, the U.K. MHRA, and Health Canada recently came together for a symposium on GCP with focus on the ICH E6 harmonized guideline and two other key topics.
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The Results Are In — Survey Reveals Barriers & Opportunities In Site Sustainability
3/27/2024
Get a better understanding of site-level dynamics with 2024 release of the Society for Clinical Research Sites' (SCRS) Site Landscape Survey.
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Reducing The Number Of Clinical Holds On Cell And Gene Therapies: Approaches For Sponsors And The FDA
3/25/2024
There is a large proportion of clinical trials for cell and gene therapies that the FDA places on clinical hold. Why is this, and what can sponsor companies and the FDA do differently?
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The Rise, Fall, And Eventual Rebound Of DCTs
3/25/2024
First there was skepticism, then enthusiasm, and then disillusionment. DCTs have had their ups and downs. Here, we're looking ahead to the future of DCTs.
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Fine-tuning Analytical Development Strategies For Every Phase
3/22/2024
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
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AI Technologies Drive Drug Development And Enhance Patient Experience In Neurology & Rare Diseases
3/21/2024
Digital healthcare and AI technologies play a crucial role in exploring and treating a range of rare diseases as we welcome a new era of personalized care and potentially better patient outcomes.
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No CRO? No Problem As Curadev Tackles Site Selection For Its First Clinical Trial
3/21/2024
Curadev COO and CFO Manish Tandon discusses the company's first foray into site selection (all without a CRO), covering a site’s influence on patient recruitment and centricity.