Blog

Explore our latest articles, insights, and stories from the frontlines of clinical trials.

Topics

All breast cancer trials fertility preservation travel vaccines autoimmune flare management gene therapy trials

Guide to Genomic Oncology DPIAs and Adaptive Protocol Amendments

Practical Q&A on DPIAs, multinational dossier readiness, seasonal adaptive amendments and a regulatory playbook for MENA academic sponsors — with timeline optimization and market research insights.

Robert Maxwell Oct 02, 2025

breast cancer protocols Trop-2 therapies Type 2 diabetes RWE psoriatic arthritis trials

How to Improve Trials: Biomarker Access, Trop-2 & MDD/Diabetes

A focused analysis of trial improvement: standardizing breast cancer biomarkers for access, commercial drivers for Trop-2 therapies, and retention strategies for MDD and diabetes with seasonal decentralized enrollment tactics.

Robert Maxwell Sep 30, 2025

breast cancer biomarkers Trop-2 therapies Major depressive disorder decentralized trials

How to Navigate Expedited Oncology INDs, Trop-2, IRB & BCI SaMD

Regulatory momentum is accelerating for expedited oncology INDs, Trop‑2 combinations and BCI SaMD. This analysis outlines FDA/EMA signals, safety and IRB harmonization trends, and actionable steps for sponsors and patients.

Robert Maxwell Sep 30, 2025

breast cancer trials Trop-2 therapies Major depressive disorder Brain-computer interface