Regulatory Insights
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Global Prevalence And Clinical Trials Landscape Of AML
4/8/2024
Explore the advancements in Acute Myeloid Leukaemia treatments, specifically innovative drugs, ongoing clinical trials, and their potential impact on patient outcomes.
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Strategic Management Of The Mature Product Portfolio
4/7/2024
Explore a new outsourcing paradigm that integrates expertise, regulatory knowledge, efficiency, and cost containment, moving beyond traditional low-cost offshore staffing models.
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Advancing Development Of New Oncology Therapies
4/4/2024
Learn how the FDA's Project FrontRunner expedites cancer drug approval for early advanced metastatic cancer, emphasizing efficacy and safety in earlier clinical settings.
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Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence
3/15/2024
Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.
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psiXchange: Intelligent, Automated Clinical Trial Safety Reporting Software
3/15/2024
Discover how intelligent, automated clinical trial safety reporting software can enhance compliance, reduce costs, and boost site responsiveness rates effortlessly.
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Handling Substantial Modifications Under The CTR
3/15/2024
The transition of ongoing clinical trials to meet CTR requirements can be challenging. Examine some key considerations, including substantial modification processes and strategic dossier updates.
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FDA Continues Diversity Push
3/15/2024
Review the FDA's revised 2016 diversity guidance, which establishes clear expectations and standardizes recommendations for gathering and reporting race and ethnicity data.
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Preparing Now For FDA’s START Program For Rare Disease Drug Developers
3/14/2024
Delve into this overview of the START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.
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Bringing In Vitro Diagnostics To Market With Real-World Evidence
3/14/2024
Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.
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Key Insights From The FDA's DHT Guidance
3/12/2024
Check out a summary of the FDA’s guidance Framework for the Use of DHTs in Clinical Trials and what it means for sponsors and investigators using these innovative tools.