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Heading to OCT SoCal tomorrow? Protocol complexity remains one of the biggest drivers of study delays, amendments and rising costs, yet many of these challenges can be identified and addressed long before a study begins...

Real-world data is playing an increasingly important role in clinical development and ICH GCP E6(R3) Annex 2 provides important guidance for its use. Speaking with Clinical Trials Arena, ICON's Wendy DeSpain notes that ...

Enriching for “fast progressors” can dramatically shorten trials in slow‑moving diseases, but only if the biomarkers are chosen wisely. See how therapeutic developers are implementing biomarkers in trial enrollment beyon...

The FDA Pre-Submission process remains one of the most valuable opportunities to reduce uncertainty for AI-enabled SaMD developers. A well-structured Pre-Sub can help organisations: - Align on evidence requirements -...

What if you could cut development timelines by up to 12+ months while reducing costs and operational complexity? At #CPHIMilan, discover how ICON's Manufacturing & Pharmacy Services combine formulation development, GMP m...

A new cross-specialty framework is reshaping how MASLD developers think about patient identification. The 2026 cardiovascular-kidney-metabolic (CKM) syndrome guidelines endorse PREVENT equations that standardise multi-or...

AI is transforming medical writing, but should it replace experts? For complex regulatory documents such as clinical study reports (CSRs), scientific judgement, interpretation and accountability remain essential. In our...

The EU Packaging and Packaging Waste Regulation (PPWR) is reshaping packaging requirements across pharma and medtech. From sustainable packaging and harmonised labelling to new technical and digital requirements, organis...

Join ICON Biotech at OCT Southern California on 15–16 September at the Hyatt Regency La Jolla at Aventine, San Diego. Visit our team at Booth \#26. We welcome the opportunity to connect with biotech sponsors to discuss ...

Before restricting a trial to “marker‑positive” patients, developers must ask whether they’re excluding people who could still benefit, and potentially shrinking their future label. ICON’s Peter Schueler and Jack Martin ...

Robust statistical analysis plans are essential for the appropriate reporting of clinical trials and the reproducibility of findings, particularly for cell and cell-based gene therapies, where treatment pathways and outc...

Shift the publishing odds to your favour. Journals & Congresses offers comparable rejection rate insights. Review rejection rates by journal to better target the right fit for your submission. Check out our interactive d...