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A reliable AI eye
for missed-signal risk.

Safety AI overview

AI analyzes large volumes of lecture slides and scientific materials in minutes*1. With detection accuracy above 99%*2, it strongly supports human review and helps minimize the risk of missed safety signals.

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Trial detection available

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Safety AI overview

*1... Estimated processing time assumes standard file sizes. Larger volumes or more complex files may take longer.
*2... Accuracy may vary depending on product type, source material, and context. To reduce missed detections from a safety perspective, the AI may produce a certain level of over-detection.

PROBLEMS

Do you face challenges like these
when checking and reporting adverse events?

Risk of missed reporting

It is becoming difficult to sustain a manual review operation that can reliably support deadline-based reporting.

Risk of missed reporting

Rising outsourcing costs

Outsourcing to CROs creates recurring annual costs that can reach tens or even hundreds of millions of yen.

Rising outsourcing costs

Growing workload

Reviewing large volumes of materials and extracting information requires significant time and labor, pushing teams close to their operational limit.

Growing workload

Concerns about using AI

Many teams hesitate to adopt AI because of concerns about missed detections, false positives, fit with company rules, and final accountability.

Concerns about using AI
SOLUTION

Safety AI helps reduce
missed-reporting risk and operational workload.

Simply upload a file and the AI will analyze whether adverse events are present in minutes*1, then notify you of the results.

1
STEP 01 - Preparation
Upload your files

Just upload files such as congress presentations and lecture slides. The service supports PDF, Word, PowerPoint, Excel, and other common formats.

2
STEP 02 - Analysis
Safety AI analyzes automatically

It handles cross-page context and chronological interpretation, enabling high-accuracy detection even in complex document structures.

Minutes*1
to complete analysis
0%+
Detection accuracy for adverse events*2
3
STEP 03 - Notification and reporting
Receive detection results by email

You receive an email summary of the decision results, and can access a linked report in PPT or Excel format showing the relevant passages and the reasons for each judgment.

1 / 1

[Shaperon AI] Detection of safety-reporting targets is complete.

Shaperon AI

To Safety Team

Apr 03 10:00

Shaperon AI has completed the detection of safety-reporting targets.

- Analysis time: Apr 03 10:00

- File: Renagliflozin_Lecture_Slides_2026.pdf

- Detected pages: p1, p6, p8, p9

- Link to analysis results
https://app.box.com/XXXXXXXX

Reply
Forward

*1... Estimated processing time assumes standard file sizes. Larger volumes or more complex files may take longer.

*2... Accuracy may vary depending on product type, source material, and context. To reduce missed detections from a safety perspective, the AI may produce a certain level of over-detection.

WHY US

Three reasons teams choose us

1
High-accuracy detection
  • Detection accuracy for adverse-event pages exceeds 99%*2. The system is designed to maintain that level of accuracy consistently across repeated runs.
2
Handles complex and varied document structures
  • It handles tasks that are difficult for general-purpose AI, including cross-page context understanding and chronological interpretation, allowing it to pinpoint exactly where the relevant content appears.
3
Flexible tuning for company-specific rules
  • The model can be customized to each company’s operational rules and decision criteria, including proprietary definitions of reportable events, so practical accuracy can be built quickly for real-world workflows.

*2... Accuracy may vary depending on product type, source material, and context. To reduce missed detections from a safety perspective, the AI may produce a certain level of over-detection.

Consult us about any safety-information workflow challenge

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USE CASES

Example use cases

Case 1Use it as a pre-check before human review

AI analyzes materials before a human reviewer does. By identifying where adverse events are likely to appear across large volumes of material, it sharply reduces the time spent searching for relevant passages.

Pre-check before human review
Case 2Use it as a double-check after human review

Use AI after human review to validate the result. The double-check helps prevent missed signals and also provides reassurance when the AI likewise finds no reportable event.

Double-check after human review
CUSTOMER VOICES

What customers said after using the service*3

90% of pharmacovigilance
professionals

said the service detects adverse events without misses.

The psychological burden
was greatly reduced

When the system also found nothing, we were able to conclude with confidence that no case was present.

Review time decreased

Using it as a support tool shortened the time needed to confirm missing adverse events and identify relevant cases.

It helped prevent misses
inside tables and graphs

The AI detected adverse-event descriptions embedded in tables and graphs that had been missed during outsourced review.

*3... This content is based on feedback and survey responses from clients and has been edited for presentation.

FUTURE PLANS

Planned service expansions

In addition to further improving detection accuracy, we plan to gradually expand the service toward semi-automating the workflow from adverse-event detection through reporting-form entry.

Coming Soon
Semi-automated report entry

Comprehensively extract adverse events, patient identifiers, outcomes, causality, and other details linked to suspect-drug cases to support entry into reporting formats.

Coming Soon
Expanded detection perspectives

Detect not only adverse events but also special situations such as pregnancy exposure, product-use errors, and drug interactions.

Coming Soon
Expanded detection channels

Detect safety information across diverse channels and formats, including daily reports, scientific papers, call centers, and chat logs.

FLOW

Implementation flow

Contact1

Contact

Start by contacting us. We will discuss options based on your challenges and current operational workflow.

Free trial2

Free trial

Using your actual materials, you can confirm the AI’s accuracy and output format.

Initial setup3

Initial setup

If the free trial meets your needs, we tune the model for implementation. We spend about one to three months adjusting it to your company-specific decision criteria and validating operations.

Go live4

Go live

After launch, we continue improving accuracy to support your safety-information management workflow over time.

FAQ

Frequently asked questions

Yes. Journal articles are included in the test data.
Yes. It can also perform compliance checks at the same time.
Yes. We can discuss adding review criteria beyond adverse events and special situations after understanding your specific examples.
Potentially, yes. Please contact us if you have a specific use case in mind.

Trial detection available

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[Important notes]

This service is intended to support detection and does not replace pharmacovigilance operations. Final confirmation and judgment remain with human reviewers, and the accuracy and specifications may change over time.

  • *1... Estimated processing time assumes standard file sizes. Larger volumes or more complex files may take longer.
  • *2... Accuracy may vary depending on product type, source material, and context. To reduce missed detections from a safety perspective, the AI may produce a certain level of over-detection.
  • *3... This content is based on feedback and survey responses from clients and has been edited for presentation.
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