"one-stop" service for drug clinical research
Provide phase I, II, and III clinical trial research services of drugs for global drug R&D institutions:Center screening,subject selection,trial management,SMO,project audit, biological sample analysis and detection,data management and statistical analysis,and regulatory affairs consulting.
With more than 36,000 registered members, it has served more than 100 enterprises at home and abroad, participated in more than 200 clinical trials, and successfully enrolled more than 10,000 subjects.
The service network covers more than 30 central cities such as Beijing, Shanghai, Wuhan, Guangzhou, Shenzhen and Changsha, with more than 100 professional project managers. With more than 20 large-scale hospitals cooperating and jointly constructing clinical research centers (including Phase I Clinical Laboratory), it has more than 1000 clinical trial standard beds and can independently arrange ethics and trials.
3.biological sample analysis
The analysis laboratory covers an area of over 50,000 square feet and is built according to ISO 9001, CNAS 17025 system and GLP standard. It has advanced instruments and equipment such as LC-MS/MS, ICP-MS, GC-MS, UPLC and high-throughput sequencing meter. The only Waters DMPK joint laboratory in the world has been established and is one of the three joint laboratories of Waters in China (China Pharmacopoeia Commission, Tsinghua University and Shanghai Jiaotong University); For 3 consecutive years, the full score passed the interstitial evaluation in the pharmacokinetic biological sample testing room of the Ministry of Health. We have successfully developed more than 100 bioanalysis and detection methods for drugs, and have the experience and ability to solve the challenges of bioanalysis for various types of drugs.
4.Data Management and Statistical Analysis
According to international standards, clinical data management, PK parameter calculation and biometric analysis services are provided, and the on-site verification pass rate is 100%.
Two major solutions and eight information systems cover the whole process of clinical trials and have profound information technology strength.
After July 22, more than 137 clinical studies of BE/PK and phases I-iv were carried out, with an average ISR (reanalysis of test samples) of 98% (international standard > 67%). The formal success rate is 100%, the verification pass rate is 100%, and the spot check pass rate is 100%. The completed project covers cardiovascular and cerebrovascular diseases, tumors, digestion, respiratory system, nerve, endocrine and metabolism, mental diseases, infectious diseases and other fields.