Pre-Clinical Safety Intelligence
Know your before FDA does.
Upload your pre-clinical package. ClinShield reviews it against every FDA and ICH rule that triggers a hold -- MRSD calculated, gaps flagged, risk scored.
The analysis that used to take consultants six months. Done in one afternoon.
Your documents are processed and immediately discarded.
Never stored, never used for training, never shared.
You have done this before. The doubt is still there.
You reviewed it three times. You will review it again.
Because one missed requirement triggers a hold that costs 12 months.
Twelve studies. One wrong number.
One transcription error in NOAEL selection cascades through every downstream calculation.
The deadline is fixed. The data is not.
Every previous submission, you made the same trade: thoroughness or speed.
How it works
Upload
Upload your pre-clinical package. PDF or Word. Up to 25 documents per assessment.
Analyze
ClinShield validates against 200+ FDA and ICH rules. Every finding maps to a specific regulatory requirement with page-level citations from your source documents.
Report
Compliance score, clinical hold risk prediction, MRSD verification with audit trail, and prioritized action items.
See What You'll Get
A real readiness report from ClinShield. Results you can verify.
Common Error Pattern
MRSD Miscalculation from Multi-Species Allometric Scaling
A pre-clinical package contains NOAEL data from rat and dog studies. The sponsor calculates HED for each species independently, then selects the lower value. The arithmetic is correct. The species selection is not.
The most sensitive species -- the one that shows dose-limiting toxicity at the lowest exposure -- should drive the MRSD. When the wrong species anchors the calculation, the starting dose shifts. Sometimes higher than it should be.
This error class accounts for a significant share of MRSD-related clinical holds. The calculation looks right on paper. The regulatory logic behind the species selection is where it breaks.
ClinShield flags species selection inconsistencies before submission. Your team confirms the correct anchor species. The MRSD holds up to FDA review.
Before ClinShield vs. After
What would a clinical hold cost your program?
in unrealized revenue from a single clinical hold.
145 days. One nonclinical deficiency. That is the average.
Day 0
Deficiency exists.
Sponsor unaware.
$0
Day 30
FDA imposes
clinical hold.
$0
Day 175
Hold lifted after
145-day remediation.
$37M
Day 365
Program recovers.
12 months lost.
$87M
Day 0 $0
Deficiency exists. Sponsor unaware.
Day 30 $0
FDA imposes clinical hold. Clock starts.
Day 175 $37M
Hold lifted after 145-day remediation.
Day 365 $87M
Program recovers. 12 months lost.
What Triggers a Hold
Three error classes. Three ways to lose a year.
MRSD Miscalculation
Wrong species anchors the allometric scaling. Starting dose shifts above safe threshold. FDA flags it on Day 30.
Caught at: MRSD verification stage
Incomplete Species Justification
Toxicology package omits rationale for species selection. Reviewer cannot confirm relevance to human pharmacology.
Caught at: Study inventory review
NOAEL Extraction Errors
NOAEL pulled from the wrong table or study timepoint. Every downstream calculation inherits the error silently.
Caught at: Cross-study data extraction
Every day a hold persists, your program burns cash.
| Trial Phase | Daily Burn Rate |
|---|---|
| Phase I | $7,829/day |
| Phase II | $23,737/day |
| Phase III | $55,716/day |
Source: Tufts CSDD 2024
Burned since you started reading (Phase III rate)
$0.00Calculate your exposure
Enter your program parameters. See what a clinical hold would cost you.
Select your program parameters above to calculate exposure.
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Program Coverage
Annual regulatory coverage. Not one-off reports.
Launchpad
- 2 assessments per year per program
- Findings mapped to FDA/ICH requirements
- Email support
Sentinel
- Unlimited assessments
- Delta reports when rules change
- Priority support
Command
- Multi-program coverage
- Dedicated success manager
- White-glove onboarding
10 companies. Permanent pricing. Direct founder access.
Founding Program closes when onboarding capacity is reached.
founding member spots
Permanent Rate
Your founding rate never increases.
Quarterly Strategy Call
30 minutes with Karaiman Feroz, MSc Regulatory Affairs and Quality Assurance. Strategy, not support.
Roadmap Influence
Shape what gets built in Year 1.
14 Months for 12
Two months free on any tier.
Founding members receive priority access to the Advocate Program.
Frequently asked questions
ClinShield is an analytical tool -- your regulatory team reviews every finding and makes the final submission decision. We publish our rule coverage so you know exactly what is checked and what is not.
ChatGPT generates probabilistic text and will confidently produce wrong MRSD calculations. ClinShield uses deterministic rules built from published FDA and ICH requirements -- every finding cites the specific page in your source document.
No. ClinShield runs the mechanical checks in hours. Your consultant brings strategic judgment, FDA meeting experience, and submission narrative expertise.
We update the rule set when new guidance publishes. Sentinel and Command customers get previous assessments re-scored against new requirements with a delta report.