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innovations during the drug
discovery phase.
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 ...
Six Questions to Discuss with Planned Sites Before Activation
Site startup for a clinical trial will always be a challenge. Why? While driving the ...
The Pillars of Driving Change with a Patient-Centric Focus
As a panelist at CORE (Clinical Operations Retreat for Executives) East, hosted in ...
How KASA Impacts Regulatory CMC Submission Strategy
Planning, assembling, and editing a Chemistry, Manufacturing, and Controls (CMC) dossier ...
AI-Driven Transformation in Clinical Research
Halloran’s CORE East, a three-day intensive retreat for clinical operations executives ...
Boston Business Journal’s Power 50: The Movement Makers Selects Halloran
Boston (November 16, 2023) – The Boston Business Journal’s Power 50: Movement Makers is ...