Studia is a cloud‑based authoring platform that lets medical writers create regulatory documents in a familiar Word‑like editor while automatically integrating relevant guidelines and historical trial data. Its AI assistant generates first‑draft content with built‑in citations, and a continuous quality engine performs real‑time compliance checks, redundancy detection, and inconsistency alerts, delivering submission‑ready protocols, ICFs, IBs, and more on the first iteration.
Funding
Funding not disclosed
Founders
Product
Problem
Regulatory medical writers must manually cross‑check multiple guidelines (ICH, EMA/FDA, CTR/MDR, etc.) across Word documents, PDFs, and web portals, leading to lengthy, error‑prone processes and delayed clinical trial submissions.
Solution
Studia provides a cloud‑based authoring platform that integrates regulatory guidelines and historical trial data directly into a familiar, Word‑like editor. Its AI assistant generates first‑draft content that is grounded in the relevant regulations and past study information, eliminating manual citation work. All source materials—including ClinicalTrials.gov, EU CTIS, PubMed, and internal SOPs—are linked, searchable, and automatically cited within the document. Real‑time compliance verification, redundancy detection, and inconsistency checks run continuously, flagging violations before review. The platform produces export‑ready regulatory documents (protocols, ICFs, IBs, etc.) that meet audit requirements on the first iteration, reducing amendment cycles and accelerating study timelines.
Target Audience
Primary users are medical writers, regulatory affairs professionals, and clinical research teams at pharmaceutical sponsors, CROs, and independent research practices.
Features
- Word‑style editor optimized for regulatory documents with built‑in compliance prompts
- AI‑driven draft generation that references up‑to‑date ICH, EMA/FDA, CTR/MDR guidelines and prior trial data
- Automatic linking and citation of external databases (ClinicalTrials.gov, EU CTIS, PubMed) and internal repositories
- Continuous quality engine that checks for guideline violations, redundancies, and logical inconsistencies
- Searchable knowledge hub that consolidates all source materials for instant retrieval
- Export functionality that produces submission‑ready files compliant with regulatory standards