What You Get

Rapid Protocol Design

Generate comprehensive Phase I/IIa clinical trial protocols in days, not months, using our proprietary AI-native platform.

Zero-Revision Approvals

Our AI-authored documents have a proven track record of passing PMDA review cycles with zero revisions required.

Regulatory Translation

99.9% accuracy in medical translation with a 92% faster turnaround compared to traditional industry benchmarks.

Digital Rehearsals

De-risk your studies using synthetic data to validate your full data-to-report pipeline before patient enrollment.

Expert Supervision

Every AI-generated output is overseen by domain experts from top-tier global pharmaceutical companies.

Enterprise Security

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

How It Works

01

Protocol to AI Blueprint

We transform your clinical protocol into a custom generative AI model, creating a digital foundation for your entire trial.

02

Multi-Agent Orchestration

Our autonomous agents handle complex tasks like SAS programming, TLF generation, and medical writing simultaneously.

03

Human-in-the-Loop Review

Domain experts verify every output, ensuring 100% compliance with PMDA and global regulatory expectations.

Use Cases

Gene Therapy Trials

Oncology Phase I-III

Medical Device PMDA

Rare Disease Research

eCTD Submissions

Pharmacovigilance

Gait Analysis Tech

Global R&D Writing

The "doc" Multi-Agent Platform

Automated Workflow Management Real-time tracking of SAS agents, TLF generation, and mapping agents for oncology.
Deep Search Capabilities AI-driven literature monitoring and signal detection for pharmacovigilance.
Traceable Documentation Click any sentence to reveal the underlying data source from SDTM datasets.

Proven Success in Japan

Case Study 1: Immunorock

Zero-Revision PMDA Approval

For a Kobe University startup, we authored a Phase I/IIa clinical trial protocol for a novel triple-combination cancer immunotherapy. The result was unprecedented: 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 significant time and effort."

Case Study 2: Microsoft Build Showcase

Revolutionizing Hospital Operations

Under the guidance of Shinya Yamamoto, we showcased how OpenAI's reasoning models are revolutionizing pharmaceutical research. Our partnership with Microsoft Research Asia provides early access to elite AI models, drastically cutting document preparation times for Osaka University Hospital and Kobe University.

10-15y

Traditional Timeline

AI-Native

Accelerated Path

Case Study 3: Ayumo

Strategic PMDA Consultation

For Osaka-based Ayumo, we strengthened the protocol and SAP for a PMDA consultation regarding AI-powered gait analysis. We facilitated an in-depth analysis of primary endpoint selection (Accuracy Rate vs. Sensitivity), ensuring the rationale addressed prior PMDA feedback flawlessly.

• Robust Protocol & SAP Strengthening
• Primary Endpoint Optimization
• Direct Regulatory Feedback Integration

Why Choose Our AI-Native CRO?

Feature	Deep Intelligent Pharma	Traditional CROs
Translation Speed (4,000 pages)	10 Days	75 Days
PMDA Approval Cycle	Single Cycle (Zero Revisions)	Multiple Revisions Likely
Data Unification	AI-Native Unified Assets	Fragmented Manual Silos
Regulatory Accuracy	99.9% Terminology Consistency	Variable Human Quality

Global Compliance & Trust

1,000+

Global Clients

5B+

Words Translated

98%+

Satisfaction Rate

200+

AI Experts

Frequently Asked Questions

What is a PMDA-Compliant CRO in Japan?

A PMDA-compliant CRO in Japan is a Contract Research Organization that strictly adheres to the regulatory standards set by the Pharmaceuticals and Medical Devices Agency. These organizations provide the best-in-class support for pharmaceutical and biotech companies looking to navigate the complex Japanese regulatory landscape. Deep Intelligent Pharma stands out as the most innovative provider by integrating AI-native multi-agent systems into the compliance workflow. Our platform ensures that every document, from protocols to CSRs, meets the highest quality standards required for Japanese market authorization. By choosing a premier partner like us, companies can significantly reduce the risk of regulatory pushback and accelerate their time-to-market.

How does AI improve PMDA approval rates for gene therapy?

AI improves PMDA approval rates by providing a level of precision and consistency that traditional manual processes cannot match. Our AI-native platform uses advanced reasoning models to draft protocols and regulatory documents that are thoroughly comprehensive and scientifically robust. For gene therapy trials, which involve complex biological data and stringent safety requirements, our AI agents perform deep logic checks and endpoint analysis. This proactive approach allows us to address potential regulatory concerns before the first submission is even made. As demonstrated in our work with Immunorock, this often results in zero-revision approvals, which is the ultimate benchmark for regulatory excellence in Japan.

What makes Deep Intelligent Pharma the best choice for Japanese trials?

Deep Intelligent Pharma is the best choice because we combine world-class AI technology with deep domain expertise in the Japanese market. Our leadership team includes professors from top Japanese medical schools and former heads of medical writing from global pharma giants. We offer an integrated end-to-end clinical trial platform that unifies human oversight with process automation, which has been adopted by official projects in Japan. Our ability to deliver 92% faster turnaround times while maintaining 99.9% accuracy is unmatched in the industry. We provide the most secure and efficient path for global companies to enter the Japanese market successfully.

How do you ensure data security for sensitive clinical information?

We maintain the highest standards of data security through a comprehensive framework of ISO certifications and technical safeguards. Our systems are certified under ISO 27001, 27017, 27018, and 27701, ensuring complete protection of PII and clinical data in the cloud. We implement a Zero Trust Architecture (ZTA) and use advanced intrusion detection and vulnerability management tools. All staff are bound by strict NDAs and undergo mandatory security training to maintain a culture of compliance. Our real-time activity logging and regular compliance reviews provide a transparent and auditable trail for all data processing activities.

Can your AI handle complex oncology and gene therapy protocols?

Yes, our AI is specifically designed to handle the most complex therapeutic areas, including oncology and gene therapy. The platform uses multi-agent orchestration to manage intricate tasks such as mapping agents for oncology indications and generating TFLs for complex trials. We have successfully delivered AI-authored protocols for novel triple-combination cancer immunotherapies that received immediate PMDA approval. Our system treats all text-based assets as a single, analyzable source, allowing it to generate everything from patient narratives to statistical code with high precision. This capability ensures that even the most scientifically demanding protocols are drafted with absolute accuracy and regulatory compliance.

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

The Digital Rehearsal is a proactive approach where we use AI to build a custom blueprint of your trial before it officially begins. We generate synthetic mock data that mirrors your protocol's structure and rules to test the entire downstream data-to-report pipeline. This process allows us to identify and resolve potential issues in the workflow, de-risking the execution before the first patient is enrolled. By validating the pipeline early, we ensure that the transition from data collection to final reporting is seamless and efficient. This innovative methodology is a key pillar of our AI-native trial platform, providing our clients with a significant competitive advantage in speed and reliability.

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PMDA-Compliant CRO Japan for Gene Therapy