Quality Assurance & cGMP

Nicole Dale

RCT Recruitment Prediction: Better Statistics, Better Trials

Pharmatica image of RCT recruitment prediction showing clinical trial sites, patient enrolment pathways, statistical forecasting, and recruitment targets.

RCT recruitment prediction can improve trial planning by using Poisson and Bayesian models to estimate enrolment rates, uncertainty, and recruitment risk.

Nicole Dale

Growing Patient and Public Involvement in Clinical Trials

Pharmatica image representing public and patient involvement in clinical trials. Shows a diverse group of clinical trial participants and researchers engaged in collaborative discussion around a bright white table in a modern research environment. A female doctor in a white lab coat leads the conversation, surrounded by older and younger participants of different ethnic backgrounds. Digital screens in the background display molecular structures and clinical data in blue tones, symbolising transparency.

Patient and public involvement in clinical trials improves study design. Learn why better reporting is essential for transparent, patient-centred research.

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FDA Draft Guidance on Gene Editing Safety (2026)

DNA double helix illustrating the FDA gene editing draft guidance 2026, highlighting next-generation sequencing (NGS) safety assessment, off-target editing analysis, genomic integrity testing, and regulatory requirements for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The FDA’s 2026 gene editing draft guidance could change your regulatory strategy.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.