Halloran Insights
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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.
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Leveraging Outsourcing And Mixed Model Staffing Amid Layoffs
9/16/2024
In the face of layoffs or data-driven disruptions, choosing to adopt outsourcing or a hybrid staffing model can offer substantial cost savings by reducing overhead expenses like salaries and benefits.
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CMC Roadmap: Considerations For Small Molecules, Recombinant Proteins
8/16/2024
This presentation guides viewers through essential questions and real-world scenarios, helping to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.
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How, Why, And When To Apply For An Orphan Drug Application
8/16/2024
Gain access to strategic insights for clinical trial sponsors on targeting an orphan drug designation and the logistical considerations involved in pursuing this path from the outset.
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Catching Up With Consulting — DIA 2024 Insights
7/12/2024
Explore the insights and perspectives from the DIA 2024 Global Annual Meeting to stay informed on the latest advancements in clinical trials and regulatory landscapes shaping the pharmaceutical industry.