Phase I/II Archives - APICES CRO

First-in-Human Trials in the EU: Regulatory Requirements and Site Selection in 2026

by Egle Pavyde | May 27, 2026 | Phase I/II

Key Takeaways: First-in-human trials in the EU are governed by Regulation (EU) No 536/2014 and the EMA’s first-in-human guideline (EMEA/CHMP/SWP/28367/07 Rev 1). Sponsors must submit a complete Clinical Trial Application via the CTIS portal and obtain both Part I...

Phase I Dose Escalation Design in the EU: ICH E8, EMA Guidelines and FDA Alignment for First-in-Human Studies

by Egle Pavyde | May 20, 2026 | Phase I/II

Key Takeaways: Phase I dose escalation design in the EU is governed by ICH E8(R1), EMA first-in-human guidance (EMA/CHMP/SWP/28367/07 Rev.1), and EU Clinical Trial Regulation 536/2014 via CTIS. The classical 3+3 design is increasingly replaced by model-based...

Phase I Oncology Trials in Western Europe: The Complete Execution Guide for Biotech Sponsors (2026 Edition)

by Egle Pavyde | May 11, 2026 | News, Phase I/II

Key Takeaways: Western Europe remains the most credible environment for Phase I oncology trials in 2026. CTIS has standardised submissions but country-level execution still determines start-up speed. Spain, France, the Netherlands, and Germany each offer distinct...

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First-in-Human Trials in the EU: Regulatory Requirements and Site Selection in 2026

Phase I Dose Escalation Design in the EU: ICH E8, EMA Guidelines and FDA Alignment for First-in-Human Studies

Phase I Oncology Trials in Western Europe: The Complete Execution Guide for Biotech Sponsors (2026 Edition)

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