Blog

How to Build RWE-Driven FDA Submissions & Cross-Border Compliance

A practical, step-by-step guide to build RWE-driven FDA submissions for HR+ breast cancer, implement decentralized trial governance for elderly cohorts, and ensure GDPR-to-FDA cross-border compliance.

Data-Driven Report: Caregivers, Elderly Monitoring & Visit Burden

A data-driven analysis showing how caregiver engagement, tech-enabled remote monitoring and protocol flexibility cut visit burden, improve retention and protect safety in elderly and high-risk trials.

Guide to Integrating Decentralized Trials with Global Regulators

Practical steps to align decentralized and hybrid trials with global regulators — from safety harmonization to submitting RWE and operationalizing accelerated oncology pathways.

Expert Guide: Mapping Emotional Journeys in Patient-Centered Trials

Analytical guide to integrating emotional-journey mapping into patient-centered trials. Data from 2024–2025 show reduced dropout and better endpoints when low-burden, caregiver-inclusive designs and dynamic monitoring are used for resistant conditions.

Expert Guide: Protocol Cost, SDOH Sites, NLP Consent & Hybrid NYC

A practical, step-by-step guide to reduce protocol cost, integrate SDOH in site choice, add NLP consent audits, and run hybrid visits for elderly NYC cohorts—centered on caregiver input and advocacy feedback.

Central IRB Reliance & RWE: Regulatory Playbook for Vaccine Pivots

Practical Q&A on centralized IRB reliance, operationalizing RWE, and adaptive seamless designs to enable faster vaccine pivots and meaningful oncology label expansion — with hope and clear steps for seniors and patients.

Why RWE for AUD and Telehealth Access Will Redefine Trials?

How real-world evidence and telehealth are reshaping trial access, from AUD treatment markets to head and neck studies—practical tactics, patient outcomes, and timing insights for smarter recruitment.

Future Trials: Consent, Teleaudiology, Contingency & Swallow Rehab

Practical strategies for patient-centered trials: co-design consent for hormone-positive breast cancer, teleaudiology retention for tinnitus, contingency management for alcohol use trials, and swallowing rehab in head and neck protocols.

IRB Negotiation & Regulatory Playbook for Adaptive, Decentralized Trials

A data-driven playbook for negotiating IRBs and regulatory pathways for adaptive, decentralized trials—practical checklists, risk-based monitoring strategy, and sandbox frameworks to accelerate inclusive oncology research.