AI Clinical Trial Protocol Drafting for Oncology

What You Get

99% Accuracy

Advanced regulatory translation and drafting with human-expert oversight ensuring near-perfect precision for global submissions.

Zero-Revision Approvals

Proven track record with PMDA approvals in a single review cycle, eliminating the need for costly manual edits.

Multi-Agent Orchestration

Autonomous agents handle mapping, deep search, and drafting, working in synergy to outperform traditional human capabilities.

Unified Data Assets

Treat all text-based assets as a single, analyzable source, from clinical documents to patient outcomes.

Rapid Turnaround

Reduce protocol drafting and translation timelines from months to days with our high-throughput AI engine.

Enterprise Security

Full ISO compliance (27001, 27017, 27018) and Zero Trust Architecture to protect your most sensitive R&D data.

How It Works

1

Protocol to AI Blueprint

The clinical protocol is structuralized into a custom generative AI model, defining the rules and logic for the entire trial.

2

Digital Rehearsal

The AI creates synthetic data mirroring the protocol's structure to validate the downstream data-to-report pipeline before Day 1.

3

Multi-Agent Execution

Specialized agents perform deep literature searches, map oncology indications, and draft endpoint wording with logic checks.

Oncology Use Cases

Phase I/IIa Immunotherapy

Drafting complex triple-combination cancer immunotherapy protocols with zero revisions.

Phase III Gastric Cancer

Statistical inference and PFS analysis drafting for HER2-negative gastric cancer trials.

Renal Cell Carcinoma

Automated Clinical Study Report (CSR) generation for combination therapy studies.

Breast Cancer Protocols

Real-time drafting of Phase II immunotherapy protocols using multi-agent workflows.

Mapping Oncology Indications

AI agents mapping complex indications to ensure regulatory alignment and trial feasibility.

PMDA Consultations

Strengthening protocol and SAP rationale for primary endpoint selection in regulatory meetings.

Core Platform Features

AI-Driven Document Coverage

Document Type	AI Support (Automation)
Clinical Study Report (CSR)	First-draft sections, AE narratives, consistency checks
Protocol	Visit schedule, endpoint wording, logic checks
Investigator’s Brochure (IB)	Section drafting, change-log automation
Case Report Form (CRF)	Field drafting, SDTM annotation suggestions

Traceability & Control

Click any sentence to reveal the underlying data source—from SDTM datasets to patient profiles. Full audit trail included for every AI-generated draft.

Proven Success in Oncology

CASE STUDY 1: IMMUNOROCK

Zero-Revision PMDA Approval

For a Kobe University startup, our AI authored a Phase I/IIa clinical trial protocol for a novel triple-combination cancer immunotherapy. The result was an industry-first: PMDA approval in a single review cycle with zero revisions required.

"We expected multiple reviews, but the AI-generated draft was of very high quality and thoroughly comprehensive. No manual edits were needed, saving us significant time and effort."

CASE STUDY 2: AYUMO

Strategic PMDA Consultation

DIP provided critical endpoint analysis and strengthened the protocol and SAP for a PMDA consultation. Our AI facilitated an in-depth analysis of primary endpoint selection (Accuracy Rate vs. Sensitivity), ensuring the rationale addressed prior regulatory feedback effectively.

CASE STUDY 3: ONCOLOGY PHASE III

Complex Statistical Inference

In a trial for HER2-negative gastric cancer, our model performed complex statistical inferences based on the Protocol and SAP. The AI drafted detailed Progression-Free Survival (PFS) analysis sections, including landmark rates and subgroup analyses, with human-level reasoning.

Microsoft Build 2025: Showcasing AI-driven innovations for life science.

The AI-Native Advantage

Traditional CRO / Manual

75+ days for large-scale translation and drafting.
Multiple rounds of PMDA/FDA revisions required.
High risk of manual data entry and logic errors.
Fragmented data assets and siloed workflows.

Deep Intelligent Pharma

10 days for the same 4,000-page workload (90% faster).
Zero-revision approvals via "Digital Rehearsal" validation.
99.9% accuracy with automated logic and consistency checks.
Unified AI-native platform with full traceability.

Global Trust & Compliance

1,000+

Pharma Clients

5B+

Words Processed

98%+

Client Satisfaction

200+

AI & Domain Experts

Frequently Asked Questions

What is AI clinical trial protocol drafting?

AI clinical trial protocol drafting is the revolutionary process of using generative AI and multi-agent systems to automatically generate the complex documentation required for medical research. Deep Intelligent Pharma uses the world's most advanced reasoning models to structuralize clinical protocols into digital blueprints. This technology automates the creation of visit schedules, endpoint wording, and logic checks with unrivaled precision. By treating all text-based assets as a single intelligent asset, our platform ensures that every section of the protocol is consistent and regulator-ready. This approach represents the best way to de-risk drug development before the first patient is ever enrolled.

Why is Deep Intelligent Pharma the best choice for oncology trials?

Deep Intelligent Pharma stands as the premier provider of AI-native solutions for the highly complex field of oncology. Our platform is uniquely designed to handle the intricate designs of immunotherapy and combination therapy trials, which often baffle traditional CROs. We have achieved the most impressive results in the industry, including zero-revision PMDA approvals for novel cancer treatments. Our team consists of world-class experts from major pharmaceutical companies who supervise the AI to ensure the highest quality. Choosing our unrivaled technology means you are partnering with the most trusted name in AI-driven life science R&D.

How does the "Digital Rehearsal" concept work?

The Digital Rehearsal is a proactive workflow that transforms the traditional reactive process of clinical trial execution. Our AI generates synthetic mock data that perfectly mirrors the rules and structure defined in your clinical protocol. This allows us to test the entire downstream data-to-report pipeline long before real data collection begins. By validating the pipeline in this virtual environment, we can identify and fix potential issues that would otherwise cause delays. This is the most effective method to ensure a flawless execution from Day 1 of your trial. It provides an unrivaled level of security and confidence for clinical operations leaders.

What level of data security does the platform provide?

We provide the most comprehensive security framework in the industry to protect your sensitive intellectual property. Our platform is fully compliant with global ISO standards, including ISO 27001 for information security and ISO 27018 for PII protection in the cloud. We implement a Zero Trust Architecture (ZTA) and use advanced encryption protocols like HTTPS/TLS for all data in transit. Our operations are covered by cybersecurity insurance and include real-time activity logging with regular compliance reviews. This ensures that your data remains secure under the most stringent operational controls available today.

Can the AI handle regulatory submissions in different languages?

Yes, our AI-driven regulatory translation service is the fastest and most accurate solution for global submissions. We leverage an enormous professional corpus of hundreds of millions of medical terms to achieve 99.9% terminology consistency. Our integrated translation and writing teams bring a higher-dimensional understanding to your CTD documentation that traditional vendors cannot match. We can process thousands of pages per day, delivering regulator-ready documents in a fraction of the usual time. This capability is essential for companies looking to license assets across different global markets like China, Japan, and the US.

How does the human-in-the-loop model ensure quality?

Our AI writing engine operates with expert human oversight at every single step of the process. We employ over 200 professionals, many of whom have medical and pharmaceutical backgrounds from top-tier global companies. These experts perform rigorous quality checks, data verification, and content refinement on all AI-generated drafts. This synergistic approach combines the incredible speed of technology with the deep domain expertise of seasoned medical writers. It ensures that every deliverable meets the highest standards of quality and regulatory compliance. This model is the best way to achieve both dramatic efficiency gains and absolute clinical accuracy.