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Psoriasis trials face recruitment, endpoint, regulatory, and operational challenges that can hinder progress. Identifying common hurdles early helps sponsors streamline processes, allocate resources more effectively, and develop proactive strategies to address obstacles.
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Rare neurological trials face ethical and operational barriers that complicate study design and execution. Natural history studies and external control arms provide accepted, practical alternatives that help to de-risk development pathways, and accelerate patient access.
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The results-driven operational framework outlined herein fosters greater alignment, enhanced operational responsiveness, and streamlined data governance, ensuring that both sponsors and CROs operate as a cohesive unit rather than as siloed entities.
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Geographic atrophy (GA), affecting 5 million globally, is linked to genetic variants and benefits from imaging, AI, and biomarkers to improve trials. Integrating genetic profiling with predictive analytics enhances recruitment, retention, and personalized treatments for GA patients.
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With rigid timelines and ambitious development goals, this highly time-sensitive Phase III trial in dry eye disease required precision project management that leveraged strong site relationships, ophthalmology-specific expertise, and data-driven site selection.
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Conducting a first-in-human gene therapy trial for a rare neuromuscular disease requires precision and expertise, especially in critically ill pediatric patients with no alternatives. See how TFS responded to challenges with a risk-based project management approach.
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