Standardizing Clinical Protocols for Global Success: ICH M11 (CeSHarP)

Clinical protocols are being redefined, and ICH M11 is leading the shift.

The introduction of ICH M11 and the Clinical Electronic Structured Harmonised Protocol (CeSHarP) template provides a global standard for the framework of clinical study protocols. This global standard has been adopted by both the EMA and FDA, and it is transforming how protocols are authored, reviewed, and submitted.

But transitioning to M11 isn’t just about formatting; it’s about getting the structure, content, and intent exactly right. That’s where Med Communications delivers.

Our regulatory writing experts specialize in converting traditional clinical study protocols and in-house templates into a fully compliant ICH M11 (CeSHarP) format, ensuring precision, consistency, and clarity from the outset and aligning protocols with how global regulators actually review them. We help sponsors:

🟦 Convert legacy protocol templates into a structured CeSHarP-compliant format
🟦 Align protocol content with ICH M11 guidance and global reviewer expectations
🟦 Improve traceability and consistency across downstream documents
🟦 Facilitate submission to CTIS and clinicaltrials.gov
🟦 Anticipate EMA and FDA review priorities
🟦 Reduce review friction through clear, standardized presentation

By leveraging the M11 framework effectively, we help streamline protocol review and approval, enabling greater efficiency, fewer clarification cycles, and faster study start timelines.

As global clinical development becomes more complex, standardization is no longer optional; it’s a competitive advantage.

Let’s talk about how we can support your transition to M11.
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