Generate comprehensive study designs grounded in 2,800+ FDA guidance documents, peer-reviewed literature, and completed clinical trials.
For a Phase 2 randomized controlled trial in relapsed/refractory multiple myeloma, a parallel-group design with 1:1 randomization is recommended 1. The primary endpoint should be overall response rate (ORR) per IMWG criteria 2, with progression-free survival (PFS) as a key secondary endpoint P1. Based on completed trials with similar patient populations CT1, a sample size of 120 patients (60 per arm) provides 80% power to detect a clinically meaningful difference P2.
2,800+
Regulatory Documents Indexed
35M+
PubMed Articles Searchable
500K+
Clinical Trials Analyzed
100%
Citations Traceable
No black boxes. Every statement in your study design links back to specific FDA guidance documents, peer-reviewed literature, and completed clinical trials.
For a Phase 2 randomized controlled trial in relapsed/refractory multiple myeloma, a parallel-group design with 1:1 randomization is recommended per ICH E9(R1) statistical principles 1 2. The primary endpoint should be overall response rate (ORR) per IMWG criteria, with progression-free survival (PFS) as a key secondary endpoint P1. Analysis of completed Phase 2 myeloma trials shows median enrollment of 60-80 patients per arm CT1, supporting a sample size of 120 patients total for adequate statistical power P2.
E9(R1) Statistical Principles for Clinical Trials: Addendum on Estimands
“The primary estimand should clearly define the treatment effect of interest, including the population, variable, and handling of intercurrent events...”
View source document2,800+ regulatory documents indexed with page-level specificity and confidence scoring.
Real-time search across 35M+ peer-reviewed articles, filtered to clinical trials and meta-analyses.
500K+ completed trials with enrollment data, outcomes, and intervention details.
Every recommendation is verifiable. Every citation is traceable.
Recommendations are grounded in retrieved FDA guidance chunks, not generated from memory. Every claim maps to a specific source document.
FDA guidance 1, PubMed literature P1, and clinical trials CT1 cited separately with document titles and page numbers.
Every citation includes a direct link to the original FDA document or PubMed abstract. Verify any claim in seconds.
“We don't generate regulatory advice from memory. We retrieve it from official sources.”
From study design to submission-ready outputs
Every recommendation is grounded in FDA guidance documents and ICH guidelines, with inline citations for full transparency.
Gemini 2.5 generates comprehensive study designs including sample size calculations, endpoints, statistical considerations, and regulatory strategy.
Automatically identifies potential regulatory concerns and provides severity-rated recommendations to address them proactively.
Ask follow-up questions about your study design. The AI assistant provides context-aware answers grounded in the same source documents.