Subject Service Platform_Elixir Clinical Research

Subject Follow-up And DCT

ePRO + AI: the digital service that uses Internet software and artificial intelligence technology to manage patient compliance, collect patient data and resolve patient questions

Electronic Informed Consent

· Electronic prior informed consent

· Electronic primary informed consent

· Face recognition, ID card recognition

· Signing of the informed consent, which is authoritative, accurate and legal as it can be certified online directly via public security channel

Intelligent Follow-up

· Remote immediate communication

· Continued collection of disease data

· Direct data connection to EDC

· Intelligent patient education with videos

· Reduction of patients' drop-out rate

Drug/Sample Delivery & Local Inspection

· Samples are sent for screening after the patient sign the prior informed consent, and the investigator will assess the samples for enrollment

· Map of local examination sites for patients, appointment management (cooperative examination organizations for hemogram and lung functions, etc.)

· Drug distribution map (immediate synchronization of distribution information, 99% prefecture-level city coverage rate)

Data Security And Privacy Protection

Security Architecture

A well-established information security architecture that can ensure safe, reliable and stable operation of the platform

01

Strictly adhering to laws and regulations

· Cybersecurity Law

· Data Security Law

· Health Insurance Portability And Accountability Act (HIPAA)

· California Consumer Privacy Act (CCPA)

· General Data Protection Regulation (GDPR)
02

Strictly practicing security management

· Access security

· Data Leak Prevention (DLP)software

· Privacy and security management

· Web Application Firewall (WAF)

· Information security management system

· Security training
03

Strictly implementing safe operation

· Passing a penetration test

· Situation awareness

· S-SDLC (Secure Software Development Lifecycle)

· Behavioral auditing, etc., for security defense and intrusion detection
04

Strictly focusing on the safety of risk control

· Building an enterprise risk defense network to achieve a strategic risk prevention moat through rules, algorithms, models, strategies and other technologies

Multiple Certifications

Pursuit of the highest compliance certification

Verification for compliance with international standards

· Title 21 CFR Part 11 (International Basic Standard)

· CDISC (Data Interchange Standards)

· GAMP5 (System Verification Standards)

Passing ISO management certifications

· The Ministry of Public Security of the PRC: Information System Security Level Protection (Level 3)

· China Academy of Information and Communications Technology (CAICT), Ministry of Industry and Information Technology: Credible Cloud Enterprise-level SaaS Service Assessment and Certification

· Internationally certified: SOC2 type1 identification

· First Chinese enterprise among WHO-UMC certified suppliers

WHO Drug coding tool certified by WHO

· The first CDISC system member and registered supplier in China

· National High-tech Enterprise