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TraceDraft

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TraceDraft is Cybroscape's AI software for clinical and regulatory writing, part of the Cybroscape platform alongside GxP Copilot. It drafts Clinical Study Reports, protocols and amendments, Investigator Brochures, DSURs, IND annual reports, health authority query responses, safety narratives and Clinical Evaluation Reports. Every generated sentence links back to the source data behind it, such as an adverse event listing row, a dataset value or a protocol clause, so sponsors, auditors and regulators can walk any claim back to its origin. A review queue keeps medical writers in charge: the AI drafts, qualified people review, edit and approve. A tamper-evident audit trail and 21 CFR Part 11 electronic signatures keep the compliance evidence ready on export. Built for CROs, biotech, pharma and medical device teams.

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