AI-Powered Innovative CRO Pioneer

The AI Intelligence
Reinventing Clinical Trials

Shanghai Jiuzhang Medical Technology transforms the entire clinical trial lifecycle into standardized AI pipelines through our proprietary "Jiuzhang Clinical" full-stack collaboration system. We replace experience-driven processes with rule-driven automation, delivering 100x efficiency gains and absolute compliance for innovative drug and device development.

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Specialized AI Agents
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Atomic Execution Skills
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Structured Knowledge Templates
1000x+
Protocol Drafting Efficiency
Core AI Platform

Jiuzhang Clinical AI Collaboration System

Built on our four-layer philosophy: Rule First → Metadata First → Validation First → LLM Last. We crystallize CRO business expertise into structured templates, orchestrating intelligent agents to auto-match, validate, and deliver outputs that meet global regulatory standards.

Medical Protocol Design

Leveraging PubMed/MeSH literature search with 99+ Protocol templates to auto-generate ICH E3 compliant protocols, integrating meta-analysis and innovative statistical designs.

Protocol CSR IB

Data Management & Biostatistics

End-to-end automated SDTM/ADaM/TFL programming with SAS 9.4 dual-engine cross-validation. CDASH v2.1 compliant CRF design ensures standardized data at the source.

SAS CDISC CRF

Pharmacovigilance & Safety

Automated ICSR generation (ICH E2B R3), SUSAR determination with expedited reporting, and full DSUR/RMP compliance for multi-jurisdictional safety submissions with zero delays.

ICSR SUSAR DSUR

Regulatory Affairs & Submissions

Intelligent IND/NDA eCTD M4(R3) packaging with automated Module 1-5 assembly. Standardized generation of Pre-IND / Pre-NDA regulatory communication documents.

eCTD IND/NDA Regulatory

Quality Assurance & Audit

ISO 19011 standard audit workflows with 4-level finding classification and closed-loop CAPA management. Auto-generated full audit trail for instant regulatory inspection readiness.

CAPA Audit 21 CFR 11

Real World Studies (RWS)

STROBE-compliant designs with PSM/IPTW propensity score matching and ICH M14 safety evaluation, powering post-market assessments and indication expansion studies.

STROBE PSM RWE
Full-Lifecycle CRO

Full-Lifecycle CRO Services

From clinical strategy to audit close-out, Jiuzhang Medical Technology delivers end-to-end innovative CRO services. Our AI engines work in deep synergy with senior experts, ensuring every milestone is delivered with maximum efficiency and absolute compliance.

01. Strategy & Protocol Design

Clinical Development Plan (CDP) formulation with intelligent Phase I-IV, BE, and IIT protocol drafting. Integrating global regulatory requirements and cutting-edge statistical designs to ensure scientific and ethical compliance.

Core Deliverables
  • • Protocol (ICH E3)
  • • Investigator's Brochure (IB)
  • • Informed Consent Form (ICF)
Core Deliverables
  • • CRF & EDC Setup
  • • Data Management Plan (DMP)
  • • Statistical Analysis Plan (SAP)

02. Data & Statistical Programming

CDASH-standard CRF design with automated SDTM/ADaM dataset conversion and TFL program generation. Dual SAS engines cross-validate to ensure zero-defect data integrity.

03. Operations & Safety Monitoring

Risk-Based Monitoring (RBM) with accelerated SSU startup pipelines. Intelligent SAE/SUSAR determination with 7/15-day expedited reporting and periodic DSUR safety summaries.

Core Deliverables
  • • Monitoring Visit Reports (MV)
  • • ICSR / CIOMS-I
  • • DSUR / RMP
Core Deliverables
  • • Clinical Study Report (CSR)
  • • eCTD M4(R3) Submission Package
  • • Audit Report & CAPA

04. Regulatory Submission & Delivery

ICH E3 standard CSR authoring with eCTD-formatted FDA/EMA/NMPA submission packages. ISO 19011 internal audits ensure first-time submission success.

Clinical Research Center
Shanghai Jiuzhang Clinical Research Center

Shanghai Jiuzhang Clinical Research Center

A specialized AI-enablement platform for Investigator-Initiated Trials (IIT). We understand the tedious pain points PI teams face in protocol design, data standardization, and ethics approval. Our center fully automates mechanical documentation through AI agents, liberating clinicians to focus on their core scientific thinking.

Powering High-Impact SCI Publications

Standardized clinical research design is the foundation for top-tier high-impact SCI publications. We ensure methodological rigor and data traceability from the very beginning.

Data Sovereignty Within the Institution

Built on dedicated on-premises compute with private deployment architecture, we uphold the strict principle that medical data stays within the medical institution, fully compliant with data sovereignty regulations.

Accelerated Ethics & Project Approval

Auto-generated GCP-compliant standardized review documents accelerate the IIT project approval process for hospital research offices and ethics committees.

IIT_PROJECT_DASHBOARD
Intelligent Protocol Drafting 100%
Standardized CRF & EDC Setup 100%
Ethics Review Documentation 100%
Five-Tier Rule Engine Audit Status
FDA
CDE
ICH
EMA
PMDA
Quality & Compliance

Global Regulatory Standards & Quality Commitment

The Jiuzhang Clinical AI Platform features a built-in five-tier regulatory rule engine, fully aligned with the latest international regulations including ICH E6(R3). Every data flow and document generation withstands the most rigorous GCP inspections and top-tier journal peer review.

ICH
E6(R3) + Annex 2
Core GCP + Non-Traditional Trials
FDA
21 CFR Part 11
Electronic Records & Signatures
CDISC
SDTMIG 3.4 / ADaMIG 1.3
Global Data Submission Standards
EMA
EU CTR 536/2014
European Clinical Trial Regulation