Blog

Why does ICH E6(R3) checklist matter for IRB reliance cross-border?

ICH E6(R3) operational readiness checklist turns regulatory principles into practical controls that enable IRB reliance and streamlined cross-border ethics workflows — essential for decentralized multinational MS studies and adaptive breast cancer programs.

University Trials Boost Breast Cancer Care: Flu, Caregivers & Genomics

Five ways university trials are improving breast cancer care — from flu protections for chemo patients to caregiver checklists, genomic report communication, tech-driven trial matching and biotech partnerships.

Steps to Pandemic-Proof Trial Starts: Kaizen, Regulators & Supply

Practical Q&A on pandemic-proofing trial starts: use Kaizen maps, a regulatory harmonization playbook, predictive enrollment analytics for flu and cancer seasons, and supply-chain resilience while understanding participant rights.

4 Real-World Successes: Adaptive Monitoring to Cold-Chain Automation

{ "content": "Clinical trials today are an engineering problem as much as a medical one: synchronize people, data, cold chains and vendors across cultures and seasons. This deep dive examines four real-world successes where adaptive monitoring frameworks to reduce protocol deviations intersect ...

How to Protect During Chemo, Trial Qs, Symptom Apps & School Prep

An analytical look at layered flu protection during chemo, essential trial questions, the rise of symptom-tracking apps, and practical back-to-school strategies for pediatric cancer patients—trends, comparisons, and next steps.

Multicenter Trials Guide: eRegulatory, Risk-based Monitoring & Vendors

{ "content": "Multicenter trials increasingly hinge on orchestration: regulatory binders, monitoring strategies, seasonal enrollment swings and supplier resilience now determine timelines as much as science.\n\n<h2>Converging trends: automation, risk focus and vendor accountability</h2>\n\nAuto...

Future Cancer Trials: What to Ask About Infection, Profiling & Support

A practical guide to future cancer trials: how to manage flu and infection risk, what to ask about tumor profiling and targeted therapies, and where to find financial and travel support.

Data-Driven EMA & GDPR/HIPAA Roadmap: Oncology, Stroke, Egypt/Turkey IRB

A practical, step-by-step roadmap for oncology and stroke trials balancing EMA accelerated approval implications, GDPR/HIPAA data transfers, and IRB navigation for Egyptian and Turkish university sponsors — with patient-focused steps and questions.

Actionable Oncology: Adaptive Monitoring & Rapid Breast Recruitment

Adaptive monitoring and harmonized international operations accelerate breast cancer cohort recruitment while prioritizing patient safety and access. This analysis covers risk-based oversight, cross-sponsor alignment, and a practical patient preparation guide.