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As therapeutic approaches evolve, clinical development strategies must adapt. This collection of insights and real-world experience from Altasciences explores emerging research areas and key considerations for complex clinical trials, from study planning and participant recruitment to clinical execution and regulatory strategy.
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Complex metabolic studies can place significant demands on recruitment and clinical execution. See how Altasciences supported a multi-center Type 1 diabetes study by recruiting and randomizing 8 qualified patients in two weeks while managing intensive glucose monitoring, insulin-induced hypoglycemia procedures, and crossover study requirements.
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GLP-1 receptor agonists have transformed metabolic research, while multifunctional agonists and combination approaches are expanding the therapeutic landscape and focusing on addressing multiple unmet needs. Explore the science shaping this evolution, including emerging approaches to efficacy, tolerability, and muscle preservation, and what they could mean for the next generation of metabolic therapies.
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Orexin therapies are entering a pivotal new era, with recent regulatory milestones creating new opportunities for pharma and biotech sponsors. Hear Altasciences’ experts explore the evolving science and regulatory landscape, including abuse potential, scheduling considerations, and the importance of integrating clinical, nonclinical, and regulatory strategies early to build a stronger path to approval.
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Did you know that conducting your studies in Canada can accelerate early-phase clinical research by six to nine weeks? Discover the unique advantages of running early-phase studies on novel compounds in Canada versus other regions.
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Bringing a new therapy into the clinic? Start with the right regulatory pathway. INDs, CTAs, ethics reviews, timelines, and submission requirements vary by region—and early decisions can shape your development timeline. Our new infographic compares early-phase clinical trial pathways across the U.S., Europe, UK, Canada, and Australia in one easy-to-use resource. Explore the comparative guide.
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Psychedelic drug development presents unique considerations for study design, participant management, recruitment, safety monitoring, and research site operations. Explore key factors sponsors should consider when planning clinical studies with psychedelics and other Schedule I drugs.
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Explore the breadth of Altasciences’ expertise in clinical pharmacology studies, supporting regulatory submissions across a diverse range of therapeutic areas. Contact us to discuss your drug development needs.
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