Regulatory Insights
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Key Takeaways From The ISPE Ireland Annex 1 Event
4/12/2024
Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.
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Future Clinical Trials: Embracing Standardization And Automation
4/10/2024
Through standardized protocols and automation integration, uncover how the industry is poised to unlock new levels of productivity and innovation, advancing the development of safe and effective treatments for patients worldwide.
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Patient Diversity: Identifying Challenges, Opportunities, And Best Practices
4/10/2024
By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.
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Insights Into The Clinical Trials Landscape Of CL
4/8/2024
Uncover developments in cystic fibrosis treatment, focusing on innovative drugs, ongoing clinical trials, and their potential impact on patient outcomes.
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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.