Clinical trial protocol templates 2026
TransCelerate, FDA/NIH and ICH M11 protocol templates explained. What changed in 2026, how they relate, and how to use them in a structured content workflow.
Read postIndustry insight, compliance, and how-to on structured content management for regulated industries.
TransCelerate, FDA/NIH and ICH M11 protocol templates explained. What changed in 2026, how they relate, and how to use them in a structured content workflow.
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Topic-based authoring means writing small, self-contained units that stand alone or assemble into documents. The mechanics, failure modes, and habits.
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A CCMS that integrates with SharePoint is not the same as one that runs on SharePoint. The structural difference, and why it matters on Microsoft 365.
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Single source of truth is the most-quoted phrase in structured-content decks. What it means in a CCMS, and what decides if you really have one.
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Most technical-documentation teams underestimate their translation bill by a factor of three to five. The reason is structural, not the per-word rate.
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SPL, IDMP and eCTD treat regulatory content as data. A practical guide to what a CCMS must do to keep up with the three standards converging in 2026.
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Structured authoring in Microsoft Word for regulated industries: what it requires, the two architectural approaches, and how to choose between them.
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CCMS and DMS sound alike until an audit asks which version of a paragraph was approved, and when. Here is the difference, drawn cleanly.
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A CCMS for SharePoint and Microsoft 365: no migration, no parallel platform, no separate procurement. The structural case for keeping SharePoint.
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Technical writers adopt XML editors with conviction and quietly stop using them within eighteen months. The reasons are not what vendors think they are.
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Structured-content programs stall when experts will not adopt an XML editor. The alternative: author in Word, DITA applied behind the scenes.
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A 2020 piece on SME adoption in DITA programs. A survey of 80 companies: DITA XML complexity is the most-cited reason departments are dropped from a rollout.
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A 2017 post making a controversial claim: the most widely used XML editor in the world is Microsoft Word. The argument still holds in 2026.
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A 2017 piece on why pharma's compliance burden makes structured content management a business-process question, not a tooling question. Still holds in 2026.
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A 2016 note on what bots will demand from your content. Nine years later, the demand turned out to be exactly what was predicted: structured, modular, tagged.
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