Atlas has delivered complete, submission-ready clinical-trial document sets for some of the most demanding studies in the field — including pediatric and adolescent trials in rare inherited diseases and advanced gene therapies, where linguistic accuracy is inseparable from patient safety.
• Parent and guardian informed-consent forms
• Adult consent and re-consent documentation
• Minor assent forms calibrated across distinct age bands — each in the correct linguistic register and culturally adapted for participants and families in the target market
Every set is engineered to pass review the first time: terminology harmonized and locked across the entire document family, the correct regulatory structure for the destination market, and full alignment with international standards such as ICH–GCP, alongside the requirements of national health authorities, ethics committees, and applicable data-protection law. We hold the distinctions that regulators check for — for instance, the formal separation between adult informed consent and minor assent — because in this field a single conflated term is a compliance failure, not a stylistic choice.
- Project-specific glossaries, locked once approved and applied consistently across an entire document set
- Segment-by-segment quality assurance in industry-standard CAT platforms
- Specialist linguists trained and experienced in clinical and regulatory translation, working only within their domain and into their native language
- A compliance-first methodology that validates every deliverable against the governing standards and local regulations before it leaves our hands