Blog

Future-Proofing Clinical Trials: FDA, EMA Decentralized & Privacy

Concrete steps to align adaptive protocols with FDA, meet EMA decentralized dossier requirements for oncology, embed data privacy for multicenter recruitment, and adopt risk-based monitoring — all while prioritizing diversity and newly diagnosed patients.

Guide to Regulatory Adaptive & RWE Filing for Oncology, Obesity & Flu

Authoritative guide on regulatory submission pathways for oncology companion diagnostics, adaptive design approvals for obesity trials, and integrating RWE into flu vaccine dossiers—emphasizing diversity, global harmonization, and patient access.

Expert Advice: Empathy, PROs & Caregivers in Decentralized Trials

A story-focused look at how empathy-driven consent, PRO tools, optimized decentralized visits, and caregiver integration make trials work for people — with real examples and insider perspective.

Step-by-Step Regulatory Playbook: Flu Vaccines in Cancer Survivors

A practical, step-by-step regulatory playbook for flu vaccines in cancer survivors: define cohorts, embed AI-driven safety checks, adapt decentralized operations, and prioritize caregiver-informed market research for real-world trial success.

RBM & Adaptive Fall Staffing: eConsent Case Study (Depression)

Data-driven analysis of RBM, adaptive fall staffing, and integrated eConsent/EMR SOPs showing faster depression enrollment, improved retention, and predictions for wider adoption in preventive health trials.

Next-Gen Flu Trials: Join, Manage Autoimmune Risks, Wearables

Curious about next‑gen flu trials? This friendly Q&A covers how to join, healthy volunteer essentials, managing autoimmune risks during research, and how wearables help detect side effects and benefits.

What mRNA vaccine trials near you accept cancer and chemo patients?

Practical steps for cancer and chemo patients to find and join mRNA vaccine trials near them. Learn how to search registries, prepare documentation, ask your doctor the right questions, and use patient navigators and trial platforms to speed enrollment.

Expert Guide: From Flu-Season Visits to Sjogren's/POTS Consent

Practical steps to improve comfort, consent, and retention across flu-season vaccine visits, Sjogren's/POTS consent, healthy volunteer studies, and psychosocial support in breast cancer trials—grounded in caregiver voices and clinician survey data.

Data-Driven Recruitment: Breast Cancer, Sjogren's, POTS & Obesity

Stories from Maria, Ahmed, and community volunteers show how culturally tailored recruitment, language-access strategies, and socioeconomic data transform trial enrollment and outcomes.