01 Advancing clinical trials rapidly

Rapid advancement reflects the overall strength of the company! Breaking one record after another

Example 1: Phase III clinical trial of tumors, 525 cases were enrolled in 10 months at the time of the COVID-19 outbreak, the CSR was submitted 6 months in advance!

Example 2: Phase III clinical trial of tumors, 730 cases were enrolled 3 months in advance;

Example 3: Rescue Study T2DM Phase III clinical trial, 24 centers were launched rapidly and 200 cases were enrolled in 7 months;

Example 4: Phase I+Ib clinical trial of the innovative drug, 32 cases of dose climbing were enrolled in 9 months, and 72 cases of extended trials were enrolled in the next 6 months

02 Experts Team 

Experts team with in-depth knowledge of international clinical trials

Professor Li Shuting, VP, Senior Medical Consultant: Former head of the GCP Office of the Cancer Hospital of the Chinese Academy of Medical Sciences; 

Professor Meng Fanqiang, CEO: Former Vice President of Peking University Sixth Hospital, 20 years of clinical trial experience in China and US;

Professor Qu Fenglian, Senior Medical Consultant: Former chief physician of Cancer Hospital of the Chinese Academy of Medical Sciences, PI;

Jiang Shunling Chief Nurse: Former Chief Nurse of Phase I Ward of Cancer Hospital of the Chinese Academy of Medical Sciences;   

03 First-level international data management system

• First-level international data management platform/EDC system

Oracle’s OC-RDC-TMS system: Obtained permanent usage riggt in 2011, combined with many independent intellectual property rights to suit pharmaceutical R&D in China; InForm: Signed the big customer agreement in 2014, purchased and applied InForm Central Designer, having reduced H&J customers’ cost by 1/3; Being the first Chinese CRO to purchase the Magnsoft CDMS/EDC (2007); Being the first Chinese CRO to purchase the Bio-Know EDC (2009);

• First-level international data management team

Key members received systemic OC-RDC training in US; 

Perfect DM team and DBM team and SOPs; 

Over half-year work and study experience for key members in US; 

Independent Data Mangement Office Building;

• Rich experience on projects in and out of China

Multi-center clinical trials at 26 centers in USA and 6 countries in South America; 

A big-scale 600 center diabetes clinical trial in China; 

CCC study of 120, 000 cases of ACS syndrome in China; 

All projects have adopted the CDISC/CDASH Criteria;

• Strong IT support system

First-level IT team;

IDC computer room facilities meet international standards; 

Standardized Disaster Backup (DB) and Disaster Recovery (DR) system (Bejing-Shanghai-New Jersey); Uninterrupted Power Supply system and independent large-power diesel generator power supply system;

04 Perfect TMF management system

Internationally advanced Clinical Trial Master File System (CTMFS);

 e-Submission system for NDAs to FDA; 

Meeting the standards according to DIA-2016 TMF-Reference Model and CFDA regulations; 

Electronic file management, paper file storage, specially designed standard storage boxes and storage room certified by ISO-9000;

05 Full-Scale Training System

Training SOPs: Can’t do the work without successful training; 

Professional training deparment (H&J College): Lead by company VP; 

Purchase and Independently developed training system: Online training and online testing; 

Department Training Standards: Continued education, hand-by-hand education;