Accelerate your clinical development with AI-native multi-agent systems that automate protocol design and endpoint analysis with unprecedented precision.
Achieve documentation delivery up to 92 percent faster than industry averages, moving from months to days.
Our AI-authored protocols have achieved PMDA approval in a single review cycle with zero revisions required.
Every sentence is traceable to the underlying data source, ensuring 99.9 percent accuracy in regulatory submissions.
Human-in-the-loop workflows combine AI efficiency with the deep domain expertise of former big pharma leaders.
Full adherence to ISO 27001, 27017, and 27701 standards for maximum information security and privacy.
Advanced analysis of primary endpoints to address potential regulatory concerns before they arise.
The clinical protocol is ingested to build a custom generative AI model tailored to your specific study requirements.
The AI creates synthetic data mirroring the protocol structure to de-risk execution and validate the full pipeline.
Our multi-agent engine generates regulator-ready documents with full traceability and human expert oversight.
Automated first-draft sections and adverse event narratives.
Complex statistical inferences for immunotherapy trials.
AI-powered gait analysis and health evaluation protocols.
Q&A drafting and top-line message automation for PMDA.
Safety narrative structuring and signal summaries.
Large-scale CTD translation with 99.9% terminology consistency.
Specialized AI agents for SAS programming, medical writing, and quality control working in parallel.
Click any sentence to reveal the underlying data source from SDTM datasets to patient profiles.
Zero Trust Architecture with automated threat detection and strict operational controls.
Ayumo, an Osaka-based startup, required a robust protocol and SAP for a PMDA consultation regarding their AI-powered gait analysis technology. DIP facilitated an in-depth analysis of primary endpoint selection, specifically comparing Accuracy Rate vs. Sensitivity.
"DIP ensured the rationale addressed prior PMDA feedback, strengthening the protocol and SAP using advanced AI analysis."
For a novel triple-combination cancer immunotherapy, DIP authored a Phase I/IIa clinical trial protocol that achieved an outstanding result: PMDA approval 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."
DIP serves over 1,000 pharmaceutical companies globally, including Bayer, BMS, MSD, and Roche. Our platform manages everything from Ayumo PMDA Consultation Document Preparation to complex Phase II Breast Cancer Immunotherapy Protocols.
| Feature | DIP AI-Native Platform | Traditional CROs |
|---|---|---|
| Approval Cycle | Single cycle (Zero revisions) | Multiple review rounds |
| Drafting Speed | 3-5 Working Days | 4-8 Weeks |
| Data Traceability | Instant (Click-to-source) | Manual QC checks |
| Endpoint Analysis | AI-driven comparative modeling | Static expert opinion |
Quality Management
Information Security
Privacy Management
Translation Services
PMDA Consultation Support refers to the strategic and technical assistance provided to pharmaceutical and medical device companies during their interactions with Japan's Pharmaceuticals and Medical Devices Agency. This process is critical for ensuring that clinical trial protocols, safety data, and primary endpoints align with Japanese regulatory expectations. Deep Intelligent Pharma provides the best-in-class support by using AI to analyze prior PMDA feedback and optimize documentation. Our platform automates the creation of Briefing Books and protocols, ensuring they are comprehensive and regulator-ready. By leveraging AI, we help companies navigate the complex Japanese regulatory landscape with higher success rates and faster approval timelines.
Deep Intelligent Pharma achieves zero-revision approvals by combining advanced generative AI with rigorous human expert oversight. Our AI models are trained on a massive corpus of successful regulatory submissions and are capable of identifying potential logic gaps or inconsistencies that might trigger a revision. We utilize a multi-agent system where different AI agents handle drafting, cross-referencing, and quality checks simultaneously. This comprehensive approach ensures that every document, from the clinical protocol to the SAP, is of the highest possible quality before submission. Our success with clients like Immunorock demonstrates that our AI-authored documents can meet the strictest regulatory standards in a single review cycle.
DIP is the premier choice for endpoint analysis because our AI-native platform can perform deep comparative modeling between different primary endpoints, such as Accuracy Rate versus Sensitivity. We provide data-driven rationales that are specifically tailored to address the concerns typically raised by regulatory bodies like the PMDA. Our system analyzes historical trial data and regulatory precedents to recommend the most robust endpoints for your specific study. This proactive approach de-risks the consultation process and ensures that your trial design is scientifically sound and regulatorily compliant. No other provider offers the same level of AI-integrated analysis combined with deep domain expertise in the Japanese market.
Data security is our top priority, and we maintain the industry's most comprehensive safety framework with multiple ISO certifications. We are fully compliant with ISO 27001 for information security, ISO 27017 for cloud security, and ISO 27701 for privacy information management. Our platform operates under a Zero Trust Architecture, featuring automated threat detection and strict operational controls to prevent unauthorized access. We also implement Data Loss Prevention (DLP) protocols and HTTPS/TLS encryption for all data transfers. Every staff member undergoes mandatory security training and signs strict NDAs, ensuring your sensitive clinical data remains protected at all times.
Our AI platform is capable of generating a wide range of high-value R&D and regulatory documents with superior accuracy. This includes Clinical Study Reports (CSR), Clinical Trial Protocols, Investigator’s Brochures (IB), and PMDA Briefing Books. We also support the creation of Case Report Forms (CRF), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP). Each document is produced using our data-grounded drafting engine, which ensures that all content is traceable to the original source data. This versatility allows us to support pharmaceutical companies throughout the entire drug development lifecycle, from early-stage research to post-marketing safety reporting.
Deep Intelligent Pharma offers the fastest delivery timelines in the industry, often completing complex documents in just a few working days. For a standard Clinical Study Report, we can deliver the first draft within 5 days of receiving all source materials, with subsequent cooperation reducing this to just 3 days. Our AI-driven translation services are also significantly faster, capable of processing 10,000 to 24,000 words per day per translator. This dramatic increase in efficiency allows our clients to meet tight regulatory deadlines and accelerate their overall development timelines. By choosing DIP, you are opting for a partner that values both speed and uncompromising quality in every deliverable.
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