Blog

2026 Playbook: Harmonizing Oncology, GLP‑1 Trials for FDA Readiness

A practical 2026 playbook for synchronizing oncology and GLP‑1/tirzepatide programs: regulatory harmonization, risk-based monitoring, and a cost-effectiveness lens to drive FDA inspection readiness.

Case Studies: Oncology Trials, Neural-Device Approval & Pregnancy RWE

A patient-first analysis of three complex development pathways—multinational oncology trials, neural-interface device approvals, and pregnancy studies leveraging real-world evidence—with practical guidance for research site administrators.

Psilocybin Trials: Controlled-Substance Regulatory Roadmap Case Study

A caregiver’s call sparked a controlled-substance roadmap for psilocybin trials. This story-driven case study shows how sponsors balanced ICH E6(R3) guidance, inspection readiness, AI-assisted submissions, and timeline optimization to keep families at the center.

Trial Tactics: Adaptive Breast Amendments, Cross-Border Ethics & RWE

A story-driven look at adaptive breast amendments, cross-border ethics in stroke trials, and how RWE and eConsent workflows speed timelines while keeping patients central.

Academic Sponsor Readiness: RPM Data for Intl Oncology Trials

Data-driven analysis on how academic sponsors must standardize RPM data for international oncology submissions—trends, survey insights, patient outcomes, and pragmatic steps for IND/IDE dual pathways.

From Expedited Flu Approvals to RWE-Driven Device Trials 2026

Five practical trends shaping clinical research in 2026—from expedited flu vaccine approvals to real-world evidence for devices—plus a quick guide on what to bring to your first visit.

Adaptive Amendments, RWE, Cross-Border Delegation & eConsent Trends

Practical steps to meet regulatory expectations for adaptive amendments, integrate RWE into oncology dossiers, operationalize cross-border delegation and implement decentralized eConsent with privacy protections.