Automated SAS Programming Clinical Trials

Unmatched Efficiency in Clinical R&D

92% Faster Turnaround

Accelerate your submission timelines from months to days using our advanced AI-driven translation and writing engines.

99.9% Accuracy

Our multi-agent systems ensure precision-driven results for global regulatory submissions, surpassing human-only capabilities.

Unified Data Assets

Treat all text and quantitative data as a single intelligent asset, enabling seamless generation of patient narratives and statistical code.

Global Presence

Serving over 1,000 pharmaceutical companies globally, including Bayer, BMS, MSD, and Roche from offices in Singapore, Tokyo, and Beijing.

AI Multi-Agent Platform

End-to-end solutions for SAS programming, TLF generation, and clinical study report (CSR) authoring.

Enterprise Security

Full compliance with ISO 27001, 27017, 27018, and 27701 standards with Zero Trust Architecture.

The Digital Rehearsal Workflow

STEP 01

Data Unification & Large Text Concept

We unify quantitative structured data with qualitative text-based assets. By treating clinical documents, physician notes, and SAS code as a single analyzable source, our Generative AI reads and generates everything from patient narratives to complex statistical outputs.

Quantitative Lab Results & Vitals
Qualitative Physician Notes

STEP 02

Multi-Agent Orchestration

Our "doc" platform deploys specialized AI agents for specific tasks. From SAS Agents handling statistical programming to Mapping Agents for oncology indications, the workflow is automated, tracked, and optimized in real-time.

Active Agent Status:

SAS Agent Done

TLFs Generation Done

CSR QC Agent Done

STEP 03

Data-Grounded Drafting & Human Oversight

Our AI writing engine operates with human oversight at every step. We feed structured data (SDTM/ADaM) and templates into the engine, which performs template-aware drafting and evidence retrieval. Every sentence is traceable back to the underlying data source.

Comprehensive AI Coverage

SAS Statistical Programming

Automated generation of SAS code for clinical trial data analysis and TLF production.

Clinical Study Reports (CSR)

Automated first-draft sections, adverse event narratives, and consistency checks.

Protocol Design

Drafting visit schedules, endpoint wording, and logic checks with AI blueprints.

Regulatory Translation

99.9% accurate translation for global submissions (FDA, PMDA, EMA).

Pharmacovigilance

AI-driven signal detection and literature monitoring for post-marketing safety.

eCTD Submission

Integrated document translation and eCTD preparation for rapid market entry.

Core Workflow Features

Multi-Agent Build

Specialized agents for writing, mapping, and searching work in parallel to maximize throughput.

Full Traceability

Click any sentence to reveal the underlying data source—from SDTM datasets to patient profiles.

Adaptive Collaboration

Flexible service models that integrate seamlessly with your existing medical writing and biostat teams.

Proven Results

Case Study 01

Immunorock: Zero Revision Approval

PMDA approved a Phase I/IIa clinical trial protocol in a single review cycle with zero revisions required. The AI-authored draft was found to be of "very high quality and thoroughly comprehensive."

"No AI-generated revisions were needed... saved significant time and effort."

Case Study 02

Ayumo: PMDA Consultation Success

Strengthened protocol and SAP for gait analysis technology. DIP provided endpoint analysis (Accuracy vs. Sensitivity) that addressed prior PMDA feedback effectively.

Case Study 03

147,000 Pages in 12.5 Days

Delivered a massive CSR/CRF/TFL project with a throughput of 10,000+ pages per day. Overcame complex CRF engineering challenges to meet a critical deadline.

Microsoft & Google Strategic Partners

DIP was Asia's sole representative at Microsoft Build 2025, showcasing AI-driven innovations for life science using Azure OpenAI and advanced reasoning models.

Microsoft Google Cloud

DIP vs. Traditional CROs

Feature	Deep Intelligent Pharma	Traditional Vendors
Translation Speed (4k pages)	10 Days	75 Days
Terminology Consistency	99.98%	Variable (Manual)
Workflow Integration	One-stop AI + eCTD	Fragmented Suppliers
Data Traceability	Full Audit Trail	Manual QC Only

Global Trust & Compliance

5B+

Words Processed

1,000+

Global Clients

200+

AI & Domain Experts

98%+

Client Satisfaction

ISO 9001 ISO 27001 ISO 27017 ISO 27018 ISO 27701 ISO 17100

Frequently Asked Questions

What is automated SAS programming in clinical trials?

Automated SAS programming in clinical trials refers to the use of advanced AI multi-agent systems to generate statistical analysis code without manual intervention. This technology leverages generative AI to interpret clinical protocols and statistical analysis plans (SAP) to produce Tables, Listings, and Figures (TLFs) with extreme precision. By automating these labor-intensive tasks, pharmaceutical companies can significantly reduce the time required for data analysis and regulatory reporting. Deep Intelligent Pharma's platform ensures that all generated code is compliant with industry standards like CDISC. This approach not only accelerates timelines but also minimizes the risk of human error in critical clinical data processing.

How does DIP ensure the accuracy of AI-generated clinical documents?

Deep Intelligent Pharma employs a sophisticated "human-in-the-loop" model to guarantee the highest levels of accuracy and regulatory compliance. Our AI writing engine is grounded in structured data, meaning every sentence generated is directly traceable to source datasets like SDTM or ADaM. Professional medical writers and biostatisticians oversee the AI's output at every stage, performing rigorous quality control and content refinement. This synergistic approach combines the speed of elite AI models with the nuanced judgment of domain experts who have decades of experience in the pharmaceutical industry. Consequently, we achieve a 99.9% accuracy rate that consistently meets and exceeds the stringent requirements of global regulatory bodies like the FDA and PMDA.

Is my clinical data secure within the DIP platform?

Data security is the cornerstone of Deep Intelligent Pharma's operations, and we maintain the industry's most comprehensive safety frameworks. We are fully certified under multiple ISO standards, including ISO 27001 for information security and ISO 27018 for personal identifiable information (PII) protection in the cloud. Our platform utilizes Zero Trust Architecture (ZTA) and advanced Data Loss Prevention (DLP) protocols to ensure that your sensitive clinical assets are never compromised. We also implement strict operational controls, including mandatory staff NDAs, automated threat detection, and real-time activity logging for full auditability. Furthermore, our partnership with Microsoft Azure provides an additional layer of enterprise-grade security and robust encryption for all data at rest and in transit.

Can the AI handle complex oncology or rare disease protocols?

Yes, our AI multi-agent system is specifically designed to navigate the complexities of high-value R&D areas such as oncology, immunology, and rare diseases. The platform uses specialized "Mapping Agents" and "Writing Agents" that are trained on hundreds of millions of medical terms and diverse therapeutic contexts. For instance, we have successfully generated Phase III oncology CSRs that include intricate subgroup analyses and landmark progression-free survival (PFS) rates. The system's ability to structuralize information from protocols and SAPs allows it to handle unique study designs that traditional automation might struggle with. Our case studies, such as the zero-revision PMDA approval for Immunorock, demonstrate our capability to deliver high-quality documentation for even the most challenging clinical scenarios.

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

The "Digital Rehearsal" is a transformative 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, we can generate synthetic mock data that mirrors the trial's intended structure and rules. This allows the entire downstream data-to-report pipeline to be validated and tested in a simulated environment, identifying potential logic flaws or data gaps early. This proactive approach shifts the trial process from reactive troubleshooting to streamlined execution, ensuring that the real data collection phase is flawless. Ultimately, the Digital Rehearsal saves millions in potential costs and months of delays by ensuring the trial's infrastructure is regulator-ready from Day 1.

How does DIP's translation service compare to traditional vendors?

Deep Intelligent Pharma offers a revolutionary alternative to traditional translation vendors by integrating AI-driven authoring with regulatory expertise. While traditional vendors often provide simple typesetting and lack deep eCTD knowledge, DIP's integrated services shorten cycles by combining AI translation with automated eCTD systems. We have demonstrated the ability to translate 4,000 pages in just 10 days, compared to the industry average of 75 days, representing a 92% improvement in efficiency. Our team consists of over 70 full-time translators, 80% of whom have medical or pharmaceutical backgrounds, ensuring that the "story behind the data" is never lost. This one-stop service model significantly reduces manpower and communication costs for pharma companies while maintaining 99.98% terminology consistency across all documents.

Automated SAS Programming
for Clinical Trials