6-month CSR compilation cycles
That delay regulatory submissions and patient access
Clinical Science: Find and cite clinical evidence across every study
Sanai searches prior protocols, study reports and results across your connected systems, and drafts CSRs and integrated summaries structured to ICH E3, every answer cited to its source.
The challenge
Your clinical breakthroughs shouldn't be delayed by documentation bottlenecks
You're generating world-class clinical evidence across complex study programs. But every month your team spends manually compiling clinical documents is a month your patients wait longer for your innovation.
The strategic reality: Your competitive advantage comes from clinical innovation, not from who can compile clinical documents fastest.
Data silos
Between biostatistics, clinical operations, and medical affairs
Rich clinical datasets, inconsistent narratives
Insights trapped in tables and listings
Clinical expertise stretched thin
Across multiple study programs and therapeutic areas
Regulatory storytelling challenges
Connecting efficacy and safety across studies
Version control nightmares
Multiple drafts across teams leading to inconsistent documentation
AI that amplifies clinical intelligence
Think of it as scaling your best clinical scientist across every evidence generation need
An AI system that understands the complexity of clinical trial design and interpretation, maintaining institutional memory of your clinical development strategy
- Understands the complexity of clinical trial design and interpretation
- Maintains institutional memory of your clinical development strategy
- Scales expert-level clinical documents across therapeutic programs
- Integrates seamlessly with existing clinical data management systems
- Writes to your templates, style guides and standards
Clinical-focused capabilities
Evidence synthesis intelligence
from individual studies to integrated analyses
Real-time clinical narrative generation following ICH E3 and regulatory standards
Cross-study consistency
maintains scientific narrative continuity
Multi-indication documents
research through registration
Audit-ready traceability
full provenance from data to clinical conclusions
Capabilities
AI for clinical study reports and summaries
Intelligent clinical study reports
Transform clinical datasets, statistical analyses, and safety data into comprehensive CSRs that follow ICH E3 guidelines with proper scientific interpretation and regulatory-ready narratives.
Integrated summary generation
Automatically synthesize efficacy and safety data across multiple studies into integrated summary documents (ISE/ISS) with clear benefit-risk assessments.
Cross-study analysis
Track efficacy trends, safety signals, and population responses across your clinical development program. Generate meta-analyses and pooled safety analyses with scientific rationale.
Regulatory narrative optimization
Create compelling clinical overviews and summaries that tell your drug's story clearly for regulatory reviewers, highlighting key efficacy and safety profile.
Biomarker and endpoint integration
Seamlessly incorporate biomarker data, patient-reported outcomes, and exploratory endpoints into your overall clinical evidence package with appropriate scientific context.
Post-market evidence documents
Maintain comprehensive documentation of real-world evidence, post-marketing studies, and safety updates with regulatory impact assessments.
Results
Real impact for clinical teams
Faster CSR compilation from 6 months to 6 weeks
Reduction in clinical documentation coordination
More clinical programs with existing medical writing resources
Improved cross-study consistency and narrative quality
Why now
Every month of delay holds back patient access
Clinical documentation bottlenecks directly delay regulatory submissions and patient access to your innovations. While you're manually compiling clinical study reports, competitors with streamlined evidence generation are advancing their programs to regulatory review faster.
Coverage
From first-in-human to post-market surveillance
Early development
- Phase I dose escalation and expansion studies
- First-in-human study reports
- Proof-of-concept documentation
- Biomarker and translational research integration
Pivotal development
- Phase II/III clinical study reports
- Integrated efficacy and safety summaries
- Regulatory submission modules
- Advisory committee briefing documents
Registration and beyond
- Clinical overview and summary documents
- Benefit-risk assessment documentation
- Post-marketing commitment studies
- Real-world evidence generation
Therapeutic areas
- Oncology and precision medicine
- Rare diseases and orphan indications
- CNS and neurodegenerative diseases
- Immunology and inflammatory conditions
Customers
Validated by clinical leaders
Trusted by clinical executives at
- Fortune 500 pharma companies
- Leading biotech clinical development organizations
- Contract research organizations (CROs)
- Academic medical centers with clinical research programs
“A clinical trial document such as a protocol is a time-consuming and labor-intensive activity, taking many weeks and multiple team members to contribute. Sanai can draft in minutes and finalize in days.”
“We've cut our CSR writing time by 80% while actually improving quality and consistency across our submission documents.”
“Cross-study comparisons that used to require weeks of manual review now happen instantly with full confidence in the results.”