Chief Medical Officer

The Safety Signal
Iceberg

90% of adverse events go unreported. Your safety reports show the tip. The FDA inspection will reveal what's below the waterline. Will you be ready?

Safety Signal Visibility

What you see vs. what's lurking below

Reported AEs
47
Hidden Signals
423
Above Surface: Visible to Board
Below Surface: Hidden from View
47REPORTED423HIDDEN SIGNALS
Hidden Signal Categories
Unreported Mild AEs156
Delayed Onset Signals89
Masked by Comorbidities78
Site Under-Reporting100
90%
of signals hidden
Industry: ~90% AEs unreported

What the FDA Sees That You Don't

Your safety database shows reported events. The FDA's inspection will find everything else.

Under-Reporting Epidemic

Studies show only 1-10% of adverse events get reported. Your safety database is showing you a fraction of reality.

90%+
of AEs never reported

Delayed Signal Detection

The average time to detect a safety signal is 4+ years post-approval. By then, thousands of patients have been exposed.

4+ years
average signal detection time

FDA 483 Exposure

"Failure to report adverse events promptly" (312.64b) is among the most common FDA inspection findings. The iceberg sinks approvals.

3%
of inspections find serious deficiencies

The Hidden Liability

Every unreported AE is a potential lawsuit waiting to surface. The iceberg you can't see is the one that sinks you.

$4.7B
largest pharma safety settlement
The SlideStrike Solution

See Below the Waterline

Proactive signal detection that shows you what's hidden before inspectors find it.

Signal Detection

Hidden Signal Scanner

AI-powered analysis of safety data to surface signals hiding in your database. Find the patterns before they become 483 findings.

See Signal Detection
Site Compliance

Reporting Rate Monitor

Real-time visibility into which sites are under-reporting. Compare site AE rates to expected rates for the indication.

See Site Monitor
FDA Ready

Inspection Readiness Score

Know your exposure before the FDA arrives. Gap analysis showing exactly where your safety reporting falls short.

See Readiness Score
Executive View

Iceberg Dashboard

Board-ready visualization showing reported vs. estimated total signals. Honest safety reporting for leadership.

See Dashboard

Safety Metrics That Reveal the Iceberg

Reporting Rate

AEs per 1000 patient-years vs. expected. Low rates = hidden iceberg.

Signal Detection Time

Days from AE occurrence to database entry. Delays hide signals.

Site Reporting Variance

Coefficient of variation across sites. High variance = under-reporting.

Serious AE Ratio

SAEs as % of total AEs vs. benchmark. Unexpected ratios = missing data.

Query Resolution Time

Days to resolve safety-related queries. Aging queries = compliance risk.

FDA Readiness Score

Composite score predicting 483 finding likelihood. Know before they arrive.

Safety Questions Answered

Real questions from pharmaceutical safety leaders

QHow do you estimate unreported adverse events?

We use epidemiological models, comparative safety data, and AI pattern recognition to estimate the full iceberg from the visible tip.

QCan this help with FDA inspection preparation?

Yes. SlideStrike provides inspection readiness scores and identifies specific gaps before inspectors find them.

QHow does the site reporting monitor work?

We compare each site's AE reporting rate to expected rates based on indication, patient population, and comparator drugs.

QIs this validated for regulatory use?

SlideStrike is an analytics tool. All regulatory decisions should be made by qualified safety professionals.

QWhat safety databases do you integrate with?

We connect to Argus, ArisG, Oracle Safety, and other major pharmacovigilance platforms.

See Below Your Safety Waterline

Find the hidden signals before the FDA does.

Scan My Safety Database
Free safety audit
FDA readiness score
483 risk assessment
The iceberg you can't see is the one that sinks you. See below the waterline.