About us
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;