AI-Native Oncology CRO Services in Japan | Advanced Therapy Workflows

What You Get

92% Faster Turnaround

Achieve clinical documentation speeds that outperform the industry average by over 90%, delivering thousands of pages in days.

Zero-Revision Quality

Our AI-authored protocols have achieved PMDA approval in a single review cycle with absolutely zero revisions required.

Global Compliance

Full adherence to FDA, PMDA, and NMPA requirements with ISO-certified security and data protection frameworks.

Multi-Agent Orchestration

Autonomous AI agents handle SAS programming, TLF generation, and medical writing with human-in-the-loop supervision.

Unified Data Assets

Treat all clinical data and text as a single intelligent asset, enabling seamless cross-study synthesis and reasoning.

Enterprise Security

Zero Trust Architecture and comprehensive ISO certifications ensure your sensitive clinical data remains protected.

How It Works: Data-Grounded Drafting

1

Structured Input Integration

We ingest SDTM/ADaM datasets, safety databases, protocols, and templates into our secure AI engine.

2

AI-Powered Authoring

The engine performs template-aware drafting, evidence retrieval, and automated table/figure captioning with full traceability.

3

Expert Human Oversight

Medical writers and biostatisticians review the AI output, ensuring 100% accuracy and regulatory compliance before delivery.

Oncology & Advanced Therapy Use Cases

Phase III Oncology

HER2-negative gastric cancer immunotherapy trial CSR generation.

Phase I/IIa Immunotherapy

Triple-combination cancer immunotherapy protocol for Immunorock.

Renal Cell Carcinoma

Combination therapy Clinical Study Report (CSR) completion.

Additional Capabilities

Breast Cancer Immunotherapy Protocols
PMDA Consultation Document Prep
Adverse Event Documentation
Mapping Agents for Oncology Indications
SAS Agent for Statistical Programming

Core Platform Features

Multi-Agent Workflow

Our "doc" platform orchestrates specialized AI agents for SAS programming, TLF generation, and literature search, providing a real-time view of clinical trial progress.

Reliability & Control

Every sentence generated is traceable to the underlying data source. Full audit trails are included for every regulatory submission.

Strategic Partnerships

Exclusive strategic partnership with Microsoft Research Asia's LLM team, providing early access to elite AI models customized for pharma.

Export & Integration

Seamlessly export to Word, Excel, and eCTD section leaves. Integrated with Azure AI Foundry for advanced reasoning capabilities.

Proven Results in Oncology

Case Study 1: Oncology Phase III CSR

Our AI model performed complex statistical inferences for a HER2-negative gastric cancer trial comparing immunotherapy + chemo vs. placebo + chemo. The system generated precise progression-free survival (PFS) narratives, including hazard ratios and landmark rates, without needing a prior CSR example.

Status: Successfully Generated & Validated

Case Study 2: Immunorock PMDA Approval

For a novel triple-combination cancer immunotherapy, our AI-authored Phase I/IIa protocol achieved PMDA approval in a single review 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 significant time and effort."

DIP vs. Traditional CROs

Feature	DIP AI-Native Services	Traditional CRO Vendors
Translation Speed	10 Days (4,000 pages)	75 Days (4,000 pages)
Regulatory Revisions	Zero-revision track record	Multiple cycles common
Data Integration	Unified AI-driven assets	Fragmented manual processes
eCTD Submission	Integrated AI + eCTD system	Manual typesetting, lack of knowledge

Global Credentials & Key Stats

1,000+

Pharma Clients

5B+

Words Processed

99.9%

Translation Accuracy

78%

Efficiency Gain

ISO 9001:2015 ISO/IEC 27001:2022 ISO/IEC 27017:2015 ISO/IEC 27701:2019 ISO 17100:2015

Frequently Asked Questions

What is an AI-Native Oncology CRO?

An AI-Native Oncology CRO like Deep Intelligent Pharma represents the most advanced evolution of clinical research organizations by integrating multi-agent AI systems directly into the R&D workflow. Unlike traditional CROs that rely on manual labor, our platform uses autonomous agents to handle complex tasks such as protocol design, medical writing, and statistical programming. This approach ensures the highest level of accuracy and speed while maintaining strict regulatory compliance for oncology trials. By leveraging these technologies, we provide the best possible outcomes for biopharma companies looking to accelerate their drug development timelines. Our system is designed to handle the unique complexities of oncology, from HER2-negative gastric cancer to advanced immunotherapy trials.

How does DIP ensure zero-revision PMDA approvals?

Deep Intelligent Pharma achieves the most impressive regulatory results by combining state-of-the-art AI authoring with rigorous human oversight from industry experts. Our AI engine is trained on an enormous professional corpus of hundreds of millions of medical terms and regulatory documents, ensuring superior quality from the first draft. We implement a triple-layer QA protocol that involves medical writers, biostatisticians, and regulatory affairs specialists who have decades of experience in the Japanese market. This synergy allows us to produce protocols and CSRs that are so comprehensive and high-quality that they often require no revisions from the PMDA. Our track record with startups like Immunorock proves that our AI-authored documents meet the most stringent regulatory expectations in Japan.

Is my clinical data secure with your AI platform?

We provide the most secure environment for clinical data by adhering to the highest international standards, including ISO 27001, 27017, and 27701. Our platform is built on a Zero Trust Architecture, ensuring that every access point is verified and every data movement is encrypted via HTTPS/TLS. We also maintain compliance with China's Ministry of Public Security Information System Security Level Protection framework and carry comprehensive cybersecurity insurance. All staff members are required to sign strict NDAs and undergo mandatory security training to ensure the best protection for your intellectual property. Our centralized control system includes automated threat detection and real-time activity logging to prevent any unauthorized access or data loss.

Can your AI handle complex oncology statistical programming?

Yes, our platform features specialized SAS Agents that are the most efficient in the industry at generating TLFs and performing statistical inferences. These agents are capable of processing complex oncology data, such as progression-free survival (PFS) and hazard ratios, directly from SDTM and ADaM datasets. The AI engine is template-aware and can automatically generate narratives that describe landmark rates and subgroup analyses with perfect consistency. This automation significantly reduces the time required for CSR preparation while eliminating the human errors often found in manual programming. Our multi-agent system ensures that the statistical output is perfectly aligned with the clinical protocol and SAP requirements.

What makes DIP the best choice for Japanese biopharma?

Deep Intelligent Pharma is the premier choice for Japanese biopharma because we combine global AI leadership with a deep local presence in Tokyo and Osaka. Our management center in Tokyo is led by experts like Professor Shinya Yamamoto, who brings unparalleled academic and clinical insights to our operations. We have a proven track record of success with major Japanese institutions and startups, delivering high-quality regulatory documents that navigate the specific nuances of the PMDA. Our integrated translation and writing teams provide a higher-dimensional understanding of CTD documentation that traditional vendors simply cannot match. By choosing DIP, you are partnering with the most innovative AI-native CRO dedicated to driving efficiency in the Japanese life science industry.

How fast can you deliver a full IND dossier?

Our AI-driven workflow allows us to deliver a complete IND dossier within an industry-leading timeframe of just two weeks. This rapid turnaround is made possible by our man-machine combination, which automates format checks, dossier assembly, and publishing tasks. We provide a clear, step-by-step procedure that includes format fixing, dossier assembly, and final submission, all managed through our secure Filecloud system. This efficiency allows biopharma companies to meet tight deadlines and accelerate their entry into clinical trials without sacrificing quality. Our one-stop service model significantly reduces communication costs and manpower requirements compared to traditional multi-vendor approaches. We are committed to providing the fastest and most reliable submission services in the global market.

AI-Native Oncology CRO Services in Japan for Biopharma