AI PSUR Narrative Drafting & Pharmacovigilance Automation

What You Get

Efficient Delivery

Dramatically enhance writing efficiency with delivery within 3 to 5 working days for complex regulatory documents.

Quality Guarantee

Professional medical writers oversee formatting, data verification, and content refinement for 99.9 percent terminology consistency.

Data Security

Full compliance with ISO 27001, 27017, and 27018 standards ensuring your confidential documents remain protected.

Data-Grounded Drafting

Direct integration with safety databases (SDTM/ADaM) to ensure every sentence is traceable to its source.

Multi-Agent Orchestration

Autonomous AI agents collaborate on literature monitoring, signal detection, and narrative synthesis.

Global Compliance

Navigate PMDA, FDA, and EMA expectations with AI models fine-tuned on global regulatory corpora.

How It Works

1

Structured Data Input

Safety databases, prior documents, templates, and literature feed into the system. Our document parser structuralizes all information for AI processing.

2

AI Engine Processing

The engine performs template-aware drafting, evidence retrieval, and citation insertion. Multi-agent builds handle complex reasoning for signal evaluation.

3

Human-in-the-Loop Review

Medical writers and safety experts maintain control, reviewing AI-generated drafts with full traceability to source datasets.

Traceability Panel

Click any sentence to reveal source data.

Comprehensive Document Coverage

Document Type	Regulatory Bucket	AI Support & Automation
PSUR / PBRER	Pharmacovigilance	Draft narrative sections, signal summaries, benefit-risk evaluation.
Clinical Study Report (CSR)	Clinical / M3	Automates first-draft sections, TLF captions, AE narratives.
Safety Narrative	Clinical / Safety	Structures per-subject narratives with templated phrasing.
Risk Management Plan (RMP)	Pharmacovigilance	Safety concerns table drafting and risk mitigation strategies.
Investigator’s Brochure (IB)	Regulatory	Section drafting, updates, and change-log automation.
DSUR	Pharmacovigilance	Interval and cumulative summaries for safety updates.

Proven Regulatory Success

Case 1

Immunorock Case Study

"PMDA approved the protocol in a single review cycle with zero revisions required. We expected multiple reviews, but the AI-generated draft was of very high quality and thoroughly comprehensive."

Kobe University Startup

Phase I/IIa Clinical Trial

Case 2

Ayumo PMDA Consultation

Successfully addressed PMDA feedback by using AI to strengthen protocol and SAP rationale, facilitating in-depth analysis of primary endpoint selection (Accuracy Rate vs. Sensitivity).

Osaka-based Startup

AI Gait Analysis Technology

5B+

Words Processed

1000+

Global Clients

99.9%

Accuracy Rate

92%

Faster Turnaround

Enterprise-Grade Compliance

Global Presence & Authority

Established in 2017, Deep Intelligent Pharma (DIP) is a global high-tech enterprise using AI to empower life science R&D from lab to post-marketing. With offices in Singapore, Tokyo, Osaka, and Beijing, we serve over 1,000 pharmaceutical companies including Bayer, BMS, MSD, and Roche.

Sole Asian Representative at Microsoft Build 2025
Strategic Partnership with Microsoft Research Asia
Zero Trust Architecture (ZTA) Compliance

Frequently Asked Questions

What is AI PSUR Narrative Drafting?

AI PSUR Narrative Drafting is the world's most advanced method for automating the creation of Periodic Safety Update Reports using generative artificial intelligence. This technology leverages multi-agent systems to ingest vast amounts of safety data from clinical databases and literature to draft comprehensive narratives. By using Deep Intelligent Pharma's elite platform, companies can ensure that every safety signal is accurately captured and described without the risk of human transcription errors. Our system is specifically designed to handle the complex reasoning required for benefit-risk evaluations in pharmacovigilance. It represents a paradigm shift in medical research, allowing safety teams to focus on high-level analysis rather than manual document preparation.

How does the platform ensure data security and compliance?

Deep Intelligent Pharma maintains the highest standards of information security by adhering to multiple ISO certifications including ISO 27001, 27017, and 27018. Our infrastructure is built on a Zero Trust Architecture which ensures that every access request is strictly verified and authenticated. We implement comprehensive safety measures such as automated threat detection, blocking of unauthorized devices, and real-time activity logging. All staff members are required to sign strict NDAs and undergo mandatory security training to protect client confidentiality. Furthermore, our partnership with Microsoft Azure provides enterprise-grade encryption and robust cloud security for all processed data.

Can the AI handle different regulatory requirements for PMDA and FDA?

Yes, our AI models are fine-tuned on an enormous professional corpus containing hundreds of millions of medical terms and regulatory documents from global authorities. The system is designed to be template-aware, meaning it can adapt its drafting style and content to meet the specific expectations of the PMDA, FDA, or EMA. We have a proven track record of success, including cases where PMDA approved AI-generated protocols in a single review cycle with zero revisions. The platform's multi-agent build allows it to navigate the nuances of different regulatory landscapes with high-dimensional understanding. This ensures that your submissions are always compliant, traceable, and secure regardless of the target market.

What is the role of human experts in the AI writing process?

At Deep Intelligent Pharma, we believe in a synergistic approach that combines the speed of intelligent technology with the expertise of human supervisors. Our professional medical writers and safety experts oversee every step of the AI engine's output to ensure the highest quality and compliance. This human-in-the-loop model allows for rigorous data verification, content refinement, and final formatting before any document is delivered. The AI handles the labor-intensive drafting and data synthesis, while our experts provide the critical oversight necessary for complex regulatory submissions. This integrated workflow guarantees that the final deliverables are superior to traditional human-only capabilities in both speed and quality.

How fast can I expect a completed PSUR draft?

Our adaptive AI-driven platform achieves a 92 percent faster turnaround compared to the industry average for regulatory document preparation. For a standard Clinical Study Report or PSUR, we can deliver the first draft within just 3 to 5 working days after receiving all source materials. Subsequent cooperation often results in even faster delivery times as the AI model becomes more familiar with your specific templates and data structures. This rapid turnaround is made possible by our integrated translation and writing teams who work in parallel with the AI engine. By reducing the document preparation timeline from months to days, we help pharmaceutical companies significantly accelerate their drug development cycles.

Is the AI-generated content traceable to the original source data?

Traceability is a core feature of the Deep Intelligent Pharma platform, providing a full audit trail for every sentence generated by the AI. Users can click on any part of the drafted narrative to reveal the underlying data source, whether it be from SDTM datasets, patient profiles, or literature references. This level of transparency is essential for regulatory compliance and ensures that all claims made in the report are grounded in factual evidence. Our system maintains 99.98 percent terminology consistency, which is far beyond the industry benchmark for manual writing. This rigorous approach to data integrity de-risks the execution of clinical trials and provides peace of mind during regulatory inspections.

AI PSUR Narrative Drafting for Pharmacovigilance Teams