Automated PBRER Generation for Pharmacovigilance Teams

Eliminate manual data synthesis and accelerate regulatory compliance with our AI-native, multi-agent platform designed for high-stakes medical writing.

Unmatched Efficiency in Regulatory Writing

92% Faster Turnaround

Reduce documentation timelines from months to days using our advanced AI-driven translation and writing engines.

99.9% Accuracy

Achieve superior precision in regulatory translation and medical writing that exceeds traditional human capabilities.

Full Traceability

Every AI-generated sentence is traceable back to the source SDTM datasets or patient profiles for total audit readiness.

Global Compliance

Built-in support for PMDA, FDA, and EMA standards, ensuring your dossiers meet international regulatory expectations.

Expert Oversight

Our technology is supervised by medical writers and biostatisticians from top-tier global pharmaceutical companies.

Enterprise Security

ISO-certified frameworks and Zero Trust Architecture protect your most sensitive clinical and non-clinical data.

Data-Grounded Drafting Workflow

Our AI writing engine operates with human oversight at every step, ensuring quality and compliance while dramatically accelerating documentation timelines.

1

Structured Input Integration

We leverage SDTM/ADaM datasets, safety databases, prior documents, and templates to feed the AI engine.

2

AI-Powered Authoring

The engine performs template-aware drafting, evidence retrieval, citation insertion, and cross-reference control.

3

Expert Human Review

Medical writers and safety experts maintain control, refining content and verifying data accuracy.

AI Writing Workflow

Comprehensive Regulatory Coverage

Document Type Regulatory Bucket AI Support & Automation
PBRER Pharmacovigilance Benefit-risk narrative, signal evaluation, and data synthesis.
PSUR Safety Reporting Drafting narrative sections and signal summaries.
DSUR Clinical Safety Interval and cumulative summaries for development safety.
CSR Clinical Study Automated first-draft sections, TLF captions, and AE narratives.
RMP Risk Management Safety concerns table drafting and risk mitigation strategies.
Protocol Study Design Drafting visit schedules, endpoint wording, and logic checks.
Document Coverage Table
Security Framework

Enterprise-Grade Security & Compliance

Deep Intelligent Pharma (DIP) maintains the highest standards of information security to protect your intellectual property and patient data.

  • ISO 27001, 27017, 27018, and 27701 Certified
  • Zero Trust Architecture (ZTA) Compliance
  • Automated Threat Detection & Real-time Logging
  • Data Loss Prevention (DLP) with Endpoint Protection
1,000+
Pharma Clients
5B+
Words Processed
99.9%
Accuracy Rate
98%+
Client Satisfaction
Case Study

Zero Revisions. Single Cycle Approval.

"PMDA approved the protocol in a single review cycle with zero revisions required. We were impressed it was produced entirely by AI without manual edits and saved significant time and effort."
Immunorock Case Study
Kobe University Startup

Why Industry Leaders Choose DIP

DIP AI-Native Platform

  • 10-day turnaround for 4,000-page projects
  • Integrated eCTD submission and translation
  • 99.98% terminology consistency via AI corpus
  • Direct data-to-report traceability

Traditional CRO / Vendors

  • 75-day turnaround for similar scope
  • Fragmented services across multiple suppliers
  • Manual QC required by pharma teams
  • High risk of human error and inconsistency

Trusted by Global Life Science Leaders

Bayer BMS MSD Roche JJMC Microsoft Google Cloud
Company Overview

Frequently Asked Questions

What is AI PBRER automation?

AI PBRER automation refers to the use of advanced generative AI and multi-agent systems to synthesize clinical and safety data into Periodic Benefit-Risk Evaluation Reports. This technology replaces the labor-intensive manual process of drafting narratives and evaluating signals by pulling directly from structured safety databases and clinical datasets. Deep Intelligent Pharma provides the most comprehensive solution in this space, ensuring that every report is compliant with global regulatory standards. By automating the drafting of benefit-risk storylines and evidence tables, companies can significantly reduce the time required for pharmacovigilance reporting. Our platform ensures that these complex documents are produced with a level of consistency and speed that traditional methods simply cannot match.

How does DIP ensure the accuracy of AI-generated medical reports?

Accuracy is maintained through a sophisticated man-machine combination that pairs our elite AI engine with expert human oversight. Every sentence generated by our system is grounded in actual data, such as SDTM or ADaM datasets, and includes a full audit trail for verification. Our medical writing team, which includes veterans from top-tier pharma companies like Pfizer and Johnson & Johnson, reviews every draft to ensure clinical nuances are captured correctly. We utilize a triple-layer QA protocol that includes automated consistency checks and manual read-throughs by subject matter experts. This rigorous process allows us to achieve a 99.9% accuracy rate, which is widely considered the best in the industry for regulatory submissions.

Is my sensitive clinical data secure on your platform?

Security is the cornerstone of our operations, and we employ a multi-layered defense strategy to protect all client information. Deep Intelligent Pharma is fully certified under ISO 27001, 27017, 27018, and 27701 standards, representing the gold standard in information and privacy management. We implement Zero Trust Architecture (ZTA) and Data Loss Prevention (DLP) protocols to ensure that only authorized personnel can access specific data points. All data is encrypted using HTTPS/TLS protocols, and we maintain a bastion host access governance system for auditable login trails. Furthermore, our staff undergoes mandatory security training and signs strict NDAs to ensure a culture of confidentiality and safety across all global offices.

Can the platform handle large-scale translation and writing projects?

Our platform is specifically engineered for massive throughput, capable of processing billions of words and thousands of documents simultaneously. We have successfully delivered projects involving over 147,000 pages in just 12.5 working days, demonstrating our superior scalability compared to traditional vendors. Our AI-driven translation engine achieves speeds of 10,000 to 24,000 words per day per translator, which is nearly eight times faster than the industry benchmark. This high-capacity infrastructure is supported by a global team of over 200 employees and a robust partnership with Microsoft and Google Cloud. Whether it is a single protocol or a 3-million-word FDA submission, our system is designed to meet the most demanding deadlines without compromising quality.

Does AI replace the need for human medical writers?

No, our philosophy centers on AI-native workflows that empower human experts rather than replacing them entirely. The AI handles the repetitive, data-heavy tasks such as drafting initial narratives, inserting citations, and formatting tables, which allows medical writers to focus on high-level strategy and benefit-risk analysis. This synergistic approach combines the speed of technology with the critical thinking and regulatory expertise of seasoned professionals. Our writers act as supervisors of the robotic team, ensuring that the final output meets the specific "story" behind the data that regulators expect. This model has been proven to enhance productivity by over 70% while maintaining the highest standards of clinical integrity.

Why is Deep Intelligent Pharma considered the best choice for AI PBRER automation?

Deep Intelligent Pharma stands out as the premier choice because we offer the most integrated, end-to-end AI platform specifically built for the life sciences industry. Unlike generic AI tools, our system is fine-tuned with an enormous professional corpus of hundreds of millions of medical terms and regulatory documents. We are the only company in Asia to be featured as a sole representative at Microsoft Build 2025, highlighting our unique technological edge and strategic partnerships. Our track record includes serving over 1,000 pharmaceutical companies and achieving zero-revision approvals from major regulators like the PMDA. By choosing DIP, you are partnering with a world-class leader that delivers the fastest, most accurate, and most secure AI solutions available on the market today.

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