Halloran Insights
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Pathway To Success: How De-Risking Life Sciences Companies Leads To Investment Growth
3/7/2025
De-risking in clinical development is essential to optimizing trial success and ensuring regulatory approval and strategic decision-making at critical points in a study’s lifecycle can minimize uncertainties.
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Groundbreaking Rare Disease Drug Approval (OGSIVEO [nirogacestat])
1/16/2025
Strategic guidance helped SpringWorks Therapeutics, a biopharmaceutical company dedicated to advancing precision medicine, to refine their regulatory strategy for late-stage development.
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Bridging Continents For Clinical Development
1/16/2025
By leveraging Australia's ecosystem as a launchpad, organizations managing both early-stage and advanced development can enhance trial quality and position themselves for success.
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Turning Your Inspection Fears Into Actionable Readiness Steps
1/9/2025
Inspection readiness is a vital component of achieving FDA approval for drugs and devices, yet even seasoned clinical research professionals can face challenges in navigating the evolving regulatory landscape.
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Disrupting The Clinical Trial Ecosystem
1/9/2025
Clinical research advances healthcare, but access, opportunity, and technology are vital to overcoming barriers and improving outcomes.
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Moving Through Obstacles On The Path To Commercialization
1/9/2025
Leaders in the clinical trials field answer questions about transitioning from clinical development to commercialization and the strategic foresight, operational excellence, and adaptability required.
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Three Ways To Accelerate From Trial To Market
1/9/2025
Moving from pre-IND to IND involves preparing for FDA interactions with a focused pre-IND meeting request and package, Selecting the right CRO, and ensuring data integrity.
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Successfully Managing The Transition From Research To Development
1/9/2025
When transitioning from research to development it's important to thoroughly understand FDA requirements and engage the FDA early on, and create an efficient integrated development plan.
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483 Issues To Sites – Indicators Of Sponsor Oversight Effectiveness
10/17/2024
Explore how effective oversight is critical for companies addressing Form 483 observations identified during clinical study site regulatory inspections.
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Three Key Impacts Of ICH E6(R3) On RBQM And Oversight
9/16/2024
The drafted guideline ICH E6(R3), introduces significant updates impacting Risk-Based Quality Management. Explore three major ICH principles and key insights related to this guidance.