Clinical Trial Outsourcing Japan | AI-Native Immunotherapy Solutions

What You Get with Our AI-Native Platform

92% Faster Turnaround

Achieve massive efficiency gains in regulatory translation and document preparation, reducing 75-day timelines to just 10 days.

Zero-Revision Approvals

Our AI-authored protocols have achieved PMDA approval in a single review cycle with zero revisions required for complex cancer immunotherapies.

Enterprise-Grade Security

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

Multi-Agent Orchestration

Autonomous agents handle SAS programming, TLF generation, and medical writing under expert human supervision.

Global Regulatory Reach

Seamlessly bridge China, Japan, and US markets with integrated eCTD submission and high-accuracy regulatory translation.

Digital Rehearsals

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

The Digital Rehearsal: How It Works

01

Protocol to AI Blueprint

We transform your clinical protocol into a custom generative AI model, establishing the structural rules and logic for the entire trial lifecycle.

02

Mock Data Generation

The AI creates high-fidelity synthetic data that mirrors the protocol's structure, allowing for a "Digital Rehearsal" of all statistical outputs.

03

Pipeline Validation

The entire data-to-report pipeline is tested and validated before Day 1, ensuring flawless execution and rapid CSR delivery upon study completion.

Specialized Therapeutic Expertise

CAR-T Cell Therapy

Complex cell kinetics and safety monitoring.

Oncology Phase I-III

Advanced mapping for oncology indications.

Medical Devices

AI-powered gait analysis and health tech.

Rare Disease

Small population statistical modeling.

Immunotherapy

Triple-combination therapy protocols.

Diabetes Research

Large-scale TLF generation and QC.

Hypertension

Automated summary writing and narratives.

Pharmacovigilance

AI multi-agent signal detection.

Intelligent Clinical Trial Platform

Our "doc" platform is a multi-agent ecosystem designed to handle the most rigorous regulatory demands. From SAS agents to mapping agents, we automate the heavy lifting of clinical data management.

Multi-Agent Workflow

Simultaneous execution of SAS programming, literature search, and QC tasks.
Automated eCRF Design

DeepCapture interface for rapid data collection setup and coding.
Real-Time Traceability

Click any sentence in a draft to reveal the underlying SDTM data source.

Proven Success in the Japanese Market

CASE STUDY: IMMUNOROCK

Zero-Revision PMDA Approval for Triple-Combination Immunotherapy

Immunorock, a Kobe University startup, required a Phase I/IIa clinical trial protocol for a novel cancer immunotherapy. Using our AI-native writing engine, we produced a comprehensive protocol that passed PMDA review in a single cycle with zero revisions.

"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."

Microsoft Build 2025 Showcase

As Asia's sole representative at Microsoft Build 2025, DIP demonstrated how OpenAI's reasoning models are revolutionizing hospital operations and pharmaceutical research in Japan.

Partnership with Osaka University Hospital
Strategic collaboration with Microsoft Research Asia
Accelerated regulatory document generation

AI-Supported Regulatory Coverage

Document Type	AI Support & Automation
Clinical Study Report (CSR)	Automates first-draft sections, TLF captions, and adverse event narratives.
Investigator’s Brochure (IB)	Section drafting, updates, and change-log automation.
Clinical Protocol	Drafting visit schedules, endpoint wording, and logic checks.
Safety Narratives	Structures per-subject narratives with templated phrasing.
eCTD Submissions	Full formatting, assembly, and publishing for global regulators.

Why Choose DIP Over Traditional CROs?

Traditional CRO Outsourcing

75+ days for large-scale translation projects.
Manual QC processes prone to human error.
Reactive workflows leading to timeline slippage.
Fragmented services between multiple vendors.

DIP AI-Native Outsourcing

10 days for the same 4,000-page translation job.
Automated terminology consistency (99.98%).
Proactive "Digital Rehearsals" to de-risk execution.
One-stop integrated translation and eCTD service.

1,000+

Global Clients

5B+

Words Translated

99.9%

Accuracy Rate

200+

AI Experts

Frequently Asked Questions

What is clinical trial outsourcing in Japan?

Clinical trial outsourcing in Japan refers to the strategic practice where pharmaceutical and biotech companies partner with specialized service providers to manage various aspects of their clinical research within the Japanese regulatory landscape. This process is essential for navigating the unique requirements of the Pharmaceuticals and Medical Devices Agency (PMDA) and ensuring cultural and linguistic alignment. By outsourcing to an AI-native partner like Deep Intelligent Pharma, companies can significantly accelerate their development timelines while maintaining the highest standards of quality. Our approach integrates advanced technology with local expertise to streamline everything from protocol design to final regulatory submission. Ultimately, it allows sponsors to focus on their core scientific innovations while we handle the complex operational and regulatory heavy lifting.

How does DIP ensure the highest quality for CAR-T trials?

Deep Intelligent Pharma utilizes a sophisticated multi-agent AI ecosystem that is specifically tuned for the complexities of CAR-T and immunotherapy research. Our platform handles intricate data mapping for oncology indications and generates precise adverse event narratives that are critical for safety monitoring in cell therapy. Every AI-generated output undergoes a rigorous triple-layer review process by our team of medical experts, many of whom come from top-tier global pharmaceutical companies. This synergy between world-class technology and human expertise ensures that every document is not only accurate but also strategically aligned with regulatory expectations. We provide the most reliable solution for sponsors who cannot afford errors in their high-value clinical programs.

What makes DIP the best partner for PMDA submissions?

Our track record of achieving zero-revision PMDA approvals in a single review cycle is a testament to our superior regulatory intelligence and AI capabilities. We have deep-rooted operations in Tokyo and Osaka, led by industry veterans like Professor Shinya Yamamoto, who understand the nuances of the Japanese market. Our AI models are trained on an enormous professional corpus of hundreds of millions of medical terms, ensuring 99.98% terminology consistency. This level of precision is unmatched by traditional CROs or translation vendors who rely on manual processes. By choosing DIP, you are partnering with the most advanced AI-native firm dedicated to the Japanese life sciences sector.

How secure is my clinical data on your platform?

Security is the cornerstone of our operations, and we maintain the most comprehensive set of ISO certifications in the industry, including ISO 27001, 27017, 27018, and 27701. Our platform adheres to Zero Trust Architecture (ZTA) and implements strict operational controls, including automated threat detection and centralized access governance. All data is protected by HTTPS/TLS encryption, and we maintain a full audit trail for every action taken within the system. We also carry cybersecurity insurance and require mandatory security training and NDAs for all staff members. Your intellectual property and patient data are treated with the highest level of confidentiality and technical assurance available today.

Can DIP handle large-scale translation and eCTD projects?

Yes, our platform is designed for massive throughput, capable of processing over 10,000 pages per day with exceptional accuracy. We have successfully delivered projects involving over 200 million words and 11,000 documents for major licensing deals between China and the US. Our integrated service model combines document translation with eCTD preparation, significantly reducing the time and communication costs associated with using multiple vendors. We have achieved turnaround times that are up to 92% faster than the industry average, such as delivering 5,800 pages in just 6 working days. This scalability makes us the ideal partner for global pharmaceutical companies facing tight regulatory deadlines.

What is the "Digital Rehearsal" concept?

The "Digital Rehearsal" is a revolutionary proactive workflow that allows sponsors to validate their entire clinical trial pipeline before a single patient is enrolled. By using the clinical protocol to build a custom AI model and generating synthetic mock data, we can test the downstream data-to-report process in its entirety. This identifies potential logic gaps or statistical challenges early, effectively de-risking the execution phase of the trial. It ensures that once real patient data begins to flow, the system is already optimized for rapid analysis and CSR generation. This innovative approach is a hallmark of our AI-native platform and represents the future of efficient clinical development.

Accelerate Clinical Trial Outsourcing in Japan for CAR-T & Immunotherapy