SealScribe Blog

Translation, regulatory affairs and clinical research — straight to the point

Practical guides on informed consent forms, protocols, ANVISA/CONEP/ICH terminology, and what it takes to translate for clinical research in Brazil.

A doctor hands a clipboard with a consent form to a patient to sign in a clinic
Clinical research

Translating Informed Consent Forms Without Losing Validity

What CNS 466/2012 and Law 14.874/2024 require when translating an ICF in Brazil — and why literal translations get rejected by the ethics committee.

July 24, 2026 · 7 min read
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Clinical research

Clinical Protocols: The Terms a Bad Translation Risks

Why ICH-GCP demands absolute precision in a translated protocol — and how one swapped term in an exclusion criterion can invalidate a group of participants.

July 30, 2026 · 6 min read
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Pharmacovigilance

Pharmacovigilance: Translating Adverse Events Correctly

Why a poorly translated adverse event is a pharmacovigilance data point, not a language mistake — and what to always preserve in an SAE report.

August 06, 2026 · 6 min read
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Regulatory affairs

Package Inserts: The ANVISA Vocabulary You Must Follow

Why a drug name on a package insert follows the DCB, not a literal translation — and what else ANVISA's Controlled Vocabulary requires in regulatory documents.

August 13, 2026 · 6 min read
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Comparison

Agency vs AI vs SealScribe: Clinical Translation Compared

A direct comparison of the three paths for translating clinical research and regulatory affairs documents — confidentiality, speed, terminology, and cost.

August 20, 2026 · 5 min read