DISCOVERY
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innovations during the drug
discovery phase.
Why The FDA Modernization Act 2.0 is The Challenge Our Industry Needs
Shawn Roach, one of Halloran’s Regulatory Chemistry, Manufacturing, and Controls (CMC) ...
Clinical Trial Manager to The Rescue: The Halloran Approach
Clinical trials are essential for bringing new treatments to patients. However, not all ...
Navigating the Patient Clinical Trial Training Matrix
Content in collaboration with ScienceMedia Authors: Malachi Bierstein, Chief Commercial ...
The Value of Artificial Intelligence to Support Inspection Readiness
A Health Authority (HA) inspection of a clinical trial can occur at any time, and ...
Navigating Clinical Trial Leadership Turnover
Clinical Trial Leadership—Directors, Associate Directors, and Senior Clinical Trial ...
Three Key Impacts of ICH E6(R3) on RBQM and Oversight
The International Council for Harmonisation draft guideline, ICH E6(R3), released on May ...
Implications of FDA’s Final Guidance on Informed Consent
Are you sponsoring a clinical trial and wondering how to develop an Informed Consent Form ...
Navigating Change Management in Technology Implementation: Validation, Risk, and Adoption
Change management is the compass guiding organizations through the tumultuous waters of ...
The Good and the Bad– One Year into the EU Clinical Trial Regulation
Earlier this year, we convened at CORE, Halloran’s Clinical Operations Retreat for ...
Debate on FDA Oversight of Laboratory Developed Tests Continues
On September 29, 2023, the U.S. Food and Drug Administration (FDA) announced their ...