AI Clinical Trial CRO Japan

What You Get

92% Faster Turnaround

Achieve rapid delivery for CSR, CRF, and TFLs, processing over 10,000 pages per day with our advanced AI engine.

99.9% Accuracy

Advanced regulatory translation and medical writing that exceeds human capabilities in both speed and precision.

Zero-Revision Approvals

Protocols authored by our AI have achieved PMDA approval in a single review cycle with zero revisions required.

Multi-Agent Orchestration

Autonomous AI agents working in synergy with domain experts to manage complex clinical workflows end-to-end.

Global Compliance

Full adherence to ISO 27001, 27017, 27018, and 27701 standards for maximum data security and privacy.

Digital Rehearsal

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

How It Works: The Digital Rehearsal

1

Protocol to AI Blueprint

The clinical protocol is used to build a custom generative AI model tailored to your specific study requirements.

2

Mock Data Generation

The AI creates synthetic data that mirrors the protocol's structure and rules to test all downstream processes.

3

Pipeline Validation

The entire data-to-report pipeline is validated before Day 1, ensuring a proactive and unified workflow.

Proven Success in Japan

Case Study 01: 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 outstanding: 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

Strategic PMDA Consultation

Ayumo, an Osaka-based startup, needed a robust protocol and SAP for PMDA consultation regarding their AI-powered gait analysis technology. DIP provided deep endpoint analysis, strengthening the rationale for primary endpoint selection and addressing prior regulatory feedback effectively.

Case Study 03: Microsoft Build Showcase

Revolutionizing Hospital Operations

Under the guidance of Shinya Yamamoto, we showcased at Microsoft Build 2025 how OpenAI's reasoning models are drastically cutting document preparation times for Osaka University Hospital and Kobe University.

Core AI Capabilities

Document Type	AI Support & Automation
Clinical Study Report (CSR)	Automates first-draft sections, TLF captions, adverse event narratives, and consistency checks.
Clinical Overview (M2.5)	Cross-study synthesis, benefit-risk storyline, and evidence table generation.
Investigator’s Brochure (IB)	Section drafting, updates, and automated change-log generation.
Clinical Protocol	Drafting visit schedules, endpoint wording, and complex logic checks.
Case Report Form (CRF)	Field drafting and SDTM annotation suggestions for seamless data management.
Safety Reports (DSUR/PSUR)	Drafting narrative sections, interval summaries, and signal evaluations.

DIP vs. Traditional CROs

DIP AI-Native Services

10-day turnaround for 4,000-page translations
Integrated AI + eCTD system for shorter cycles
One-stop service reducing manpower and costs
99.98% terminology consistency via AI platforms

Traditional CRO Vendors

75-day turnaround for similar translation scope
Lack of eCTD knowledge and simple typesetting
Fragmented suppliers increasing time and risk
Significant time required for manual QC

Enterprise-Grade Credentials

5B+

Words Translated

1000+

Global Clients

200+

Domain Experts

98%+

Client Satisfaction

Frequently Asked Questions

What is an AI clinical trial CRO in Japan?

An AI clinical trial CRO in Japan, like Deep Intelligent Pharma, is a specialized contract research organization that utilizes advanced generative AI and multi-agent systems to automate the labor-intensive tasks of drug development. Unlike traditional CROs that rely heavily on manual labor, we use AI to draft protocols, generate clinical study reports, and handle regulatory translations with unprecedented speed. This approach is specifically designed to meet the rigorous standards of the PMDA while significantly reducing the time-to-market for new therapies. Our technology acts as a digital partner, ensuring that every document is compliant, traceable, and of the highest quality. By integrating AI into the core of clinical operations, we provide a more efficient and reliable alternative to traditional research models.

How does DIP ensure the highest quality in AI-generated protocols?

Deep Intelligent Pharma employs a unique man-machine combination model where our proprietary AI engine works under the constant supervision of domain experts. Our AI is trained on an enormous professional corpus of hundreds of millions of medical terms and regulatory documents, ensuring it understands the "story" behind the data. Every AI-generated draft undergoes a rigorous triple-layer QA protocol involving medical writers, biostatisticians, and regulatory affairs specialists. This synergy allows us to produce documents that are not only faster to generate but often superior in quality to those produced by human teams alone. Our success with zero-revision PMDA approvals for clients like Immunorock is a testament to the effectiveness of this high-end approach.

Is my clinical data secure with your AI platform?

Security is the cornerstone of our operations, and we maintain the most comprehensive safety certifications in the industry, including ISO 27001, 27017, 27018, and 27701. We implement a Zero Trust Architecture (ZTA) and use advanced data loss prevention (DLP) protocols with endpoint protection and HTTPS/TLS encryption. Our systems are covered by cybersecurity insurance and undergo regular compliance reviews to ensure the highest level of protection for your sensitive information. All staff are bound by strict NDAs and undergo mandatory security training to maintain a culture of confidentiality. We provide full-cycle SOPs for information security, ensuring that your data is managed with the utmost care from ingestion to final delivery.

Can your AI handle complex regulatory translations for the PMDA?

Yes, our AI-driven regulatory translation services are the best in the industry, achieving a 99.9% accuracy rate for global submissions. We utilize custom-built AI solutions that are specifically compiled by experts to grasp complex medical corpora and long-sentence structures common in clinical documentation. Our team includes over 70 full-time translators, many of whom have medical and pharmaceutical backgrounds from multinational pharma companies. This allows us to deliver high-volume projects, such as 4,000-page submissions, in as little as 10 days compared to the 75-day industry average. We don't just translate words; we author CTDs that navigate regulatory expectations with precision and deep understanding.

What are the benefits of the "Digital Rehearsal" concept?

The "Digital Rehearsal" is a revolutionary concept that allows pharmaceutical companies to de-risk their clinical trials before a single patient is enrolled. By using the clinical protocol to build a custom AI blueprint and generating synthetic mock data, we can validate the entire downstream data-to-report pipeline in advance. This proactive approach identifies potential logic errors, endpoint issues, or data management challenges early in the process, saving millions in potential costs. It transforms the clinical trial workflow from a reactive model to a proactive one, ensuring that everything is ready for Day 1 of the study. This methodology has been adopted by official projects in Japan and is a key driver of our accelerated development timelines.

How does DIP support eCTD submissions in Japan?

We provide an integrated service that combines document translation with expert eCTD preparation and submission, leveraging over 15 years of experience in international regulatory filings. Our man-machine combination model uses AI to shorten the formatting and assembly cycles, ensuring that dossiers are published and submitted with flawless precision. This one-stop service significantly reduces the communication costs and time delays associated with using multiple vendors for translation and submission. We handle everything from format checks and dossier assembly to media production and final electronic archiving. Our goal is to provide the most seamless path to regulatory approval, ensuring that your submission meets all PMDA specifications on the first attempt.