Compliance & Validation — Not documented by Atlas
Ask the vendor: Which compliance certifications (HIPAA, 21 CFR Part 11, SOC 2, GxP) do you hold?
TrialAssure
Clinical trial transparency software with generative AI (LINK AI) for drafting CSRs, plain language summaries, and regulatory documents.
TrialAssure, founded in 2009 and headquartered in Canton, Michigan, builds clinical trial transparency and disclosure software — anonymization (ANONYMIZE), registry management (REGISTRY), and LINK AI, a generative AI tool for drafting clinical study reports, plain language summaries, statistical analysis plans, and informed consent documents under a human-review workflow. Cancer Research UK's Centre for Drug Development has publicly described a phased implementation of LINK AI; broader claims such as use by top clinical development companies are self-reported. No third-party security certifications were identified on public pages at profiling time.
- Headquarters
- Canton, United States
- Founded
- 2009
- Deployment options
- cloud
- Website
- https://trialassure.com
- https://www.linkedin.com/company/trialassure
Categories
AI Use Cases
- Regulatory Submission Authoring
Vendor Scorecard
50% — Partial coverage. Coverage score — how completely Atlas documents TrialAssure across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud
Pricing Transparency — Not documented by Atlas
Ask the vendor: What is your pricing model, and what drives total cost of ownership?
Implementation & Onboarding — Not documented by Atlas
Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?
Organization & Role Fit — Documented
Mid-Size Biotech, Large Pharma, Top 20 Pharma, Regulatory Affairs, Medical Affairs
Solution Scope — Documented
Natural Language Processing, Regulatory Submission Authoring
Company Viability — Partially documented
Private, Founded 2009
Always ask the vendor
Not captured in Atlas data — confirm directly. Excluded from the score above.
Data Rights & IP
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Model Credibility & Explainability
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?
Questions to Ask This Vendor
- Which document types does LINK AI draft in production today?
- How does the human review workflow document writer accountability?
- What security certifications or audit reports can be shared under NDA?
- How is our clinical data protected during AI drafting?