Compliance & Validation — Not documented by Atlas
Ask the vendor: Which compliance certifications (HIPAA, 21 CFR Part 11, SOC 2, GxP) do you hold?
AI-driven medical-writing agency delivering regulatory, scientific, and transparency documents for clinical trials.
QInscribe, launched in 2025 and based in the United Kingdom (Hitchin, Hertfordshire), is an AI-driven medical-writing agency that combines expert medical writers with AI tooling to deliver regulatory, scientific, and transparency-focused documents supporting clinical trials for biopharmaceutical sponsors. It is a services provider rather than a self-serve software product, so engagement is project- or retainer-based and its AI tooling is delivered through its writing team. Atlas found no vendor-held security certifications documented on its site.
50% — Partial coverage. Coverage score — how completely Atlas documents QInscribe across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Ask the vendor: Which compliance certifications (HIPAA, 21 CFR Part 11, SOC 2, GxP) do you hold?
cloud
Ask the vendor: What is your pricing model, and what drives total cost of ownership?
Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?
Biotech Startup, Mid-Size Biotech, Large Pharma, Regulatory Affairs, Medical Affairs
Regulatory Submission Authoring
Founded 2025
Not captured in Atlas data — confirm directly. Excluded from the score above.
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?