Predict protocol amendments before they cost you millions.
60% of clinical trials require protocol amendments. Each one costs $500K-$1M and delays your trial by months. Prevara analyses your draft protocol against thousands of historical trials and tells you which design decisions will fail - before you enrol a single patient.
Protocol amendments are the most expensive mistake in drug development.
They happen because protocol design decisions that seem reasonable in a conference room fail in reality. The data to predict these failures exists. Nobody is using it.
of trials require at least one protocol amendment
average months of delay per substantial amendment
direct cost per amendment (regulatory, sites, systems)
estimated annual industry cost of protocol amendments
Why do protocols fail? The same reasons, every time.
Eligibility criteria too narrow
35% of amendmentsProtocol requires Rotterdam PCOS criteria + BMI 25-35 + testosterone >2.5 nmol/L. In practice, 70% of real PCOS patients fail screening. Sites can't recruit. Trial stalls.
Wrong or missing endpoints
25% of amendmentsYou chose ovarian volume as your primary endpoint. Six months in, it doesn't correlate with symptom improvement. Should have used menstrual regularity or Ferriman-Gallwey score.
Impractical visit schedules
20% of amendmentsBiweekly clinic visits for working-age women. Dropout rate hits 40%. You amend to monthly visits - after losing 6 months and half your cohort.
Safety monitoring gaps
20% of amendmentsYour GLP-1 trial for PCOS didn't include gallbladder event monitoring. FDA flags it mid-trial. Emergency amendment, 3-month delay, $800K cost.
Upload a protocol. Get back intelligence.
Not a checklist. Not a style guide. Predictive, quantitative analysis of which design decisions will cause amendments, recruitment failure, or dropout - with specific alternatives.
Upload Your Draft Protocol
PDF, Word, or structured format. Our NLP engine parses the full document - eligibility criteria, endpoints, visit schedules, sample size, safety monitoring, statistical analysis plan - and extracts every design decision.
Get Amendment Risk Predictions
Every design element is scored against historical trial data. "Eligibility criteria this restrictive have a 68% amendment rate in PCOS trials. Visit schedules requiring biweekly attendance in this population see 43% dropout." Each prediction cites the source trials.
See Specific Recommendations
"Widen BMI criteria from 25-35 to 22-40 - increases eligible population by 60%, amendment probability drops to 15%." "Switch primary endpoint from ovarian volume to menstrual cycle regularity - 3.2x stronger correlation with patient-reported outcomes in historical PCOS trials."
Ship a Better Protocol
Every recommendation is auditable, deterministic, and citable. Export a risk report for your regulatory team, your IRB submission, or your board. Track which recommendations you accepted and model the projected impact on recruitment, timeline, and cost.
Starting with women's health trials
Our deepest intelligence is in hormonal health: PCOS, endometriosis, fertility, menopause, and thyroid conditions. These trials have some of the highest amendment rates in the industry because the conditions are complex, underdiagnosed, and poorly understood by generic protocol design tools.
Protocol design hasn't changed in 30 years. Until now.
The data to predict protocol failures already exists - 400,000+ trials on clinicaltrials.gov, decades of published amendment analyses. Nobody has turned it into a predictive engine. We did.
What you do today
Medical writers draft protocols based on experience and templates
Protocol review committee meets for 2-4 weeks to debate design
Amendments discovered during the trial, after patients are enrolled
Each amendment triggers regulatory resubmission, site retraining, system changes
Post-hoc analysis of "what went wrong" after the trial ends
What Prevara does
NLP parses your draft protocol and extracts every design decision
Each element scored against historical trial outcomes in minutes
Amendment risks identified before you submit to the IRB
Specific alternative recommendations with quantified impact
Continuous learning from every protocol analysed
Less than the cost of a single amendment.
A protocol amendment costs $500K-$1M+. Preventing even one pays for the platform many times over. Most protocols have 2-3 preventable amendments.
Per Protocol
For biotech companies running 1-3 trials
- Full protocol NLP analysis
- Amendment risk scoring per design element
- Specific alternative recommendations
- Historical trial comparisons with citations
- Exportable risk report for regulatory teams
- One round of revision analysis
Platform
For pharma and CROs running multiple active trials
- Everything in Per Protocol, plus:
- Unlimited protocol analyses
- Real-time amendment risk monitoring across your portfolio
- Eligibility criteria optimisation engine
- Recruitment feasibility modelling
- Integration with your CTMS via API
- Dedicated protocol intelligence team
- Custom therapeutic area models
Send us a protocol. We'll show you where it breaks.
Share a draft protocol from an active or planned trial. On the call, we'll run it through the engine live - amendment risk scores, eligibility feasibility, endpoint analysis, and specific design recommendations. 30 minutes. No commitment.
30-minute call · We analyse your protocol live · No commitment