Enterprise Protocol
Compliance Analysis
Built to exceed ICH E6 and global regulatory standards
1 free protocol per email • No credit card required
FREE TIER
1 watermarked report (view-only)
PILOT: $500
Downloadable report - 94% off (First 10 only)
FULL PRICE: $8,500
After pilot closes
Protocol Reviews Are Killing Your Timelines
2-4 Weeks Waiting
Your trial sits idle while reviewers catch up
$25K-50K Cost
Premium pricing for inconsistent results
Vague Findings
"Consider revising section 4.2" - no specifics
Inconsistent Quality
Different reviewers, different standards
Every day delayed = $55,000 in trial costs
Enterprise-Grade Compliance Technology
Exceeds industry standards including ICH E6 (R2), FDA AI guidance, EMA requirements, and global regulatory frameworks.
Read our FDA AI Risk Assessment →Our Hybrid Approach Combines:
Deterministic checking (100% reproducible, audit-ready)
Rule-based validation ensures consistent, verifiable results every time
AI quality analysis (deep content evaluation)
Advanced NLP examines nuance, context, and clinical appropriateness
Complete evidence chains (every finding is traceable)
Full audit trail from protocol text to regulatory requirement
Regulatory-ready reports (submit with confidence)
Professional documentation meeting global regulatory standards
Score: 85/100
Grade: B - Submission Ready
Used by biotech companies to accelerate submissions and reduce regulatory risk.
The gold standard in automated protocol compliance analysis.
How It Works
Three simple steps to compliance clarity
Upload Protocol
Drag and drop your protocol document. We support PDF, Word, and more.
AI Analysis (less than 10 minutes)
Our hybrid system analyzes against ICH E6 requirements. View free watermarked report instantly, or upgrade for clean downloadable version.
Get Report
Review online or download your detailed compliance report with evidence chains.
Simple, Transparent Pricing
Choose the plan that fits your needs
Free Trial
One-time per email
- 1 protocol analysis
- Full compliance report
- View online
- Watermarked (ClinShield logo)
- No download
Perfect for:
Testing before committing
Pilot Program
$8,500
SAVE 94%
- Everything in Free
- NO watermark
- Downloadable (PDF + HTML)
- Shareable with team
- Priority support
Requirements:
Testimonial if satisfied + 30-min feedback call
Full Price
After pilot closes
- All features included
- No watermark
- Downloadable
- Priority support
- Volume discounts available
Available:
After pilot program closes
Need more than 100 protocols per year?
Contact us for Enterprise pricingThe Clear Choice
See how ClinShield compares to traditional CRO reviews
| CRO | ClinShield | |
|---|---|---|
| Turnaround | 2-4 weeks | less than 10 minutes |
| Cost | $35,000 | $500-$8,500* |
| Findings Detail | Vague | Specific |
| Evidence Chains | None | Complete |
| Revisions | +$10K | Free |
| Regulatory Alignment | Unknown | Documented |
*$500 pilot program (first 10 customers), then $8,500 per protocol
The Math Is Simple
Every day of delay costs you money
Average Phase III Trial
$20M
Cost Per Day
$55K
Save 2 Weeks
$770K
ClinShield Cost
$8.5K
Your Return on Investment
90x
For every $1 spent, you save $90 in trial delays
See Exactly What You'll Get
A real compliance report from our system
Protocol Compliance Report
ICH E6 (R2)/100
Needs improvement before submission
What's Inside Every Report
Executive Summary
Overall score, grade, and key findings at a glance
Detailed Findings
Each issue with specific protocol section references
Evidence Chains
Complete reasoning from protocol text to ICH requirement
Remediation Guidance
Actionable recommendations to address each finding
Built by Clinical Trial Veterans
The Founder
"After seeing sponsors waste months on protocol revisions that could have been caught early, I built ClinShield to automate what CROs charge $35,000 for. Every day of delay costs trials $55,000 - that's unacceptable when the technology exists to do better."
Connect on LinkedIn100% Money-Back Guarantee
Not satisfied with your compliance report? Get a full refund within 30 days. No questions asked.
Frequently Asked Questions
Ready to Accelerate Your Protocol Reviews?
Start with a free watermarked report or apply for the $500 pilot program.
Pilot limited to first 10 customers. We'll respond within 24 hours.
Questions? hello@clinshield.com