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Nicole Dale

Quality-of-Life Measurement in Patients With Metastatic Breast Cancer

Pharmatica image of patient questionnaire and clinical research documents illustrating quality-of-life measurement in metastatic breast cancer trials.

The EORTC QLQ-MBR44 is the first quality of life module for metastatic breast cancer. See what 228 interviews reveal and what it means for trial sponsors.

Nicole Dale

FDA Draft Guidance on Gene Editing Safety (2026)

DNA double helix illustrating the FDA gene editing draft guidance 2026, highlighting next-generation sequencing (NGS) safety assessment, off-target editing analysis, genomic integrity testing, and regulatory requirements for cell and gene therapy development.

The FDA’s 2026 gene editing draft guidance could change your regulatory strategy. Explore the new NGS requirements for cell and gene editing therapies.

Nicole Dale

CRO and Vendor Oversight in Clinical Trials

Clinical research professional reviewing operational data and regulatory documents on dual-monitor workstations, illustrating CRO vendor oversight in clinical trials, vendor performance monitoring, compliance management, and quality assurance across outsourced clinical research operations.

ICH E6(R3) raises the governance bar for CRO and vendor oversight in clinical trials. Here's what sponsors must build into outsourcing relationships to protect trial quality and timelines.

Nicole Dale

Ready to Deliver With Continuous Pharmaceutical Manufacturing

High-quality image of automated machinery for continuous pharmaceutical manufacturing with Pharmatica branding.

Continuous pharmaceutical manufacturing cuts production time by up to 90% and is now backed by ICH Q13. Here’s what manufacturing leaders need to know about the shift to CM.

Nicole Dale

FDA PreCheck Pilot Program to Build Manufacturing Readiness

Pharmatica image of regulatory inspectors reviewing digital drug manufacturing systems in a pharmaceutical production facility, illustrating the FDA PreCheck Pilot Program, manufacturing readiness, U.S. domestic drug manufacturing, and advanced pharmaceutical manufacturing.

The FDA PreCheck Pilot Program aims to strengthen U.S. domestic drug manufacturing through regulatory engagement, manufacturing readiness, and advanced production.

Nicole Dale

Modular Pharma Factories: The Next Step for Continuous Manufacturing?

Pharmatica image showing modular pharmaceutical manufacturing using continuous pharmaceutical manufacturing processes, interconnected production modules, and Process Analytical Technology to improve flexible drug manufacturing.

Discover how modular pharmaceutical manufacturing and continuous production could improve flexibility, resilience, and efficiency across modern pharmaceutical operations.