Clinical Guest Contributors
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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.
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Latest CISCRP Patient Survey Reveals Diversity Gaps, Yields 5 Tips For Improvement
3/20/2024
Results from the latest CISCRP “Perceptions & Insights” study reveal five opportunities to improve clinical trial recruitment and participation, especially among ethnic and racial minority groups.
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Why Small Clinical-Stage Companies Need Developmental Risk Management Plans
3/19/2024
For small clinical-stage companies, developmental risk management plans are not a regulatory requirement but a strategic imperative to proactively manage risks.
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Why The ‘Illusion’ Of Speed In Clinical Trials Unravels As Contracting Demands Scale
3/19/2024
Discover four mistakes biotechs often make in haste (and how to avoid them) as they hurry through clinical trial contracting on the path to commercilization.