PMDA-Compliant AI Clinical Trial Services & Protocol Automation

What You Get

Zero-Revision Protocols

Generate high-quality Phase I/IIa clinical trial protocols that pass PMDA review cycles with zero revisions required, saving months of back-and-forth.

92% Faster Turnaround

Reduce translation and documentation timelines from 75 days to just 10 days using our advanced AI-driven regulatory translation engine.

Unified Data Assets

Treat all text-based assets as a single, analyzable source. Our AI unifies structured lab results with unstructured physician notes seamlessly.

Multi-Agent Orchestration

Deploy specialized AI agents for SAS programming, TLF generation, and medical writing, all supervised by domain experts.

Global Regulatory Reach

Support for FDA, PMDA, and NMPA submissions with localized expertise and 99.9% terminology consistency across all documents.

Enterprise Security

Full compliance with ISO 27001, 27017, 27018, and 27701 standards, ensuring your clinical data remains secure and private.

The Digital Rehearsal: How It Works

01

Protocol to AI Blueprint

We transform your clinical protocol into a custom generative AI model, mapping out every rule and structural requirement for the trial.

02

Mock Data Generation

The AI creates synthetic data that mirrors the protocol's structure, allowing for a full-scale simulation of the trial's data flow.

03

Pipeline Validation

The entire downstream data-to-report pipeline is tested and validated before Day 1, de-risking execution and ensuring regulatory readiness.

Proven Success in PMDA-Compliant AI Clinical Trials

CASE STUDY 01: IMMUNOROCK

Zero-Revision PMDA Approval for Cancer Immunotherapy

Immunorock, a Kobe University startup, utilized our AI-native platform to author a Phase I/IIa clinical trial protocol for a novel triple-combination cancer immunotherapy. The result was unprecedented: the PMDA approved the protocol in a single review cycle with zero revisions required.

"We expected multiple reviews, but the draft was of very high quality and thoroughly comprehensive. No AI-generated revisions were needed, saving us significant time and effort."

CASE STUDY 02: AYUMO

Strengthening PMDA Consultations with AI Analysis

Ayumo, an Osaka-based startup, needed a robust protocol and SAP for a PMDA consultation regarding their "Dr. Walkie Plus" gait analysis technology. We provided deep endpoint analysis, comparing Accuracy Rate vs. Sensitivity, and strengthened the rationale to address prior PMDA feedback effectively.

Optimized primary endpoint selection
Addressed complex regulatory concerns proactively

CASE STUDY 03: THE "DOC" PLATFORM

End-to-End Knowledge Management

Our "doc" software interface provides a centralized workspace for all regulatory and study documentation. From Type 2 Diabetes Management Protocols to Renal Cell Carcinoma CSRs, the platform manages the entire lifecycle of clinical trial assets with real-time status tracking.

1,000+

Pharma Clients

5B+

Words Processed

Revolutionizing Hospital Operations & Research

Watch how our strategic partnership with Microsoft and OpenAI is redefining drug development timelines.

Why Choose Our AI-Native Approach?

Feature	Traditional CRO / Vendor	Deep Intelligent Pharma
Protocol Approval	Multiple review cycles (3-6 months)	Zero-revision PMDA approval cycles
Translation Speed	3,000 words/day (75 days for 4k pages)	24,000 words/day (10 days for 4k pages)
Data Integration	Manual, siloed data entry	Unified AI-driven data assets
Regulatory Accuracy	Human-dependent, variable quality	99.9% accuracy with expert supervision

Global Compliance & Trust

ISO 27001

Information Security

ISO 9001

Quality Management

ISO 17100

Translation Services

Zero Trust

Architecture Certified

Bayer Roche BMS MSD Merck

Frequently Asked Questions

What are PMDA-compliant AI clinical trials?

PMDA-compliant AI clinical trials refer to the use of advanced artificial intelligence and multi-agent systems to automate the generation of regulatory documents that meet the strict standards of Japan's Pharmaceuticals and Medical Devices Agency. This approach ensures that protocols, clinical study reports, and statistical analysis plans are authored with extreme precision and adherence to local regulatory expectations. By leveraging AI, pharmaceutical companies can significantly reduce the risk of revisions and delays during the consultation and approval phases. Our platform specifically integrates deep domain expertise with generative models to produce regulator-ready documentation. This represents the most efficient way to navigate the complex Japanese regulatory landscape today.

How does the AI ensure 99.9% accuracy in regulatory translation?

Our AI-driven regulatory translation service utilizes a custom-built engine trained on an enormous professional corpus of hundreds of millions of medical terms. This system is specifically designed to handle the linguistic nuances and technical complexity of clinical trial documentation, ensuring that every sentence maintains its scientific integrity. We combine this powerful technology with a triple-layer quality assurance protocol involving certified medical linguists and subject matter experts. This man-machine combination allows us to achieve a level of terminology consistency and accuracy that far exceeds traditional human-only translation methods. It is the best solution for large-scale global submissions where precision is non-negotiable for regulatory success.

Can the AI platform handle complex oncology protocols?

Yes, our platform is highly specialized in handling complex therapeutic areas, including oncology, immunotherapy, and rare diseases. We have successfully authored Phase I/IIa protocols for novel triple-combination therapies that have received zero-revision approvals from the PMDA. The AI agents are capable of performing sophisticated statistical inferences and endpoint analyses based on the specific requirements of the study protocol and SAP. This ensures that even the most intricate trial designs are documented with complete clarity and regulatory rigor. Our experience with high-value R&D writing makes us the most reliable partner for biotech startups and global pharma companies alike. We provide the technical depth necessary to support advanced medical research at scale.

What is the "Digital Rehearsal" concept in clinical trials?

The "Digital Rehearsal" is a proactive approach where we use the clinical protocol to build a custom AI blueprint and generate synthetic mock data before the trial begins. This allows us to simulate the entire data-to-report pipeline, identifying potential bottlenecks or logic errors in the protocol before any patients are enrolled. By validating the downstream processes early, we significantly de-risk the execution of the trial and ensure that the final outputs will be compliant with regulatory standards. This innovative methodology transforms the clinical trial process from a reactive one to a proactive, highly controlled operation. It is the most advanced way to ensure that your trial stays on track and meets its primary objectives without unexpected hurdles. Our clients find this rehearsal phase invaluable for securing internal and external stakeholder confidence.

How does Deep Intelligent Pharma protect sensitive clinical data?

Data security is the cornerstone of our operations, and we implement a comprehensive safety framework that complies with the highest international standards. We hold multiple ISO certifications, including ISO 27001 for information security and ISO 27701 for privacy information management, ensuring full-cycle protection for all client assets. Our technical assurance includes Zero Trust Architecture, automated threat detection, and strict operational controls such as mandatory staff NDAs and real-time activity logging. All data transfers are protected by HTTPS/TLS encryption, and we utilize bastion host access governance for auditable login trails. This provides our pharmaceutical clients with the most secure environment possible for their proprietary R&D information. We are committed to maintaining the highest level of confidentiality and integrity for every project we undertake.

What are the primary benefits of using AI for eCTD submissions?

Using AI for eCTD submissions offers a one-stop, integrated service that dramatically shortens the submission cycle compared to traditional vendors. Our platform automates the formatting, assembly, and publishing of the dossier, reducing the time and manpower required for quality control. By combining AI-driven translation with an intelligent eCTD system, we ensure that all documents are perfectly formatted and traceable to their source data. This integrated approach eliminates the need to pass documents between multiple suppliers, which often leads to communication costs and potential errors. It is the most efficient and cost-effective method for ensuring that your IND or NDA submissions are delivered on time and in full compliance with regulatory specifications. Our expertise in international eCTD submissions ensures a smooth path to market authorization.

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PMDA-Compliant AI Clinical Trials Without Revisions