Clinical trial protocol design and basic document preparation (protocol, case report form, informed consent, investigator manual, etc.)
Medical support during the clinical trial process
Writing of clinical trial summary report
Preparation of some clinical declaration material in CTD Format
Phase I- III clinical trials for innovative drugs
Clinical trials of chemical drugs, traditional Chinese medicines, medical devices, biologics, macromolecules, and specialty foods, etc
BE trials for generic drugs
Validation clinical trials for generic drug
Real-world studies
We provide a full range of site management services for clinical research centers
Covering Sichuan (Chengdu/Mianyang/Luzhou/Guangyuan), Guangxi (Nanning/Liuzhou), Yunnan (Kunming), and Guizhou (Guiyang). Currently more than 20 innovative drug projects, more than 100 BE projects, and more than 10 validation clinical projects have been accomplished
Data management: protocol review, case report form (CRF, eCRF), design, CRF annotation, writing of logical verification plan, design, creation, testing and maintenance of database, design and maintenance of randomized drug supply system (RTSM), data management plan, eCRF filling guide, data audit plan and other documents writing
Data review and challenge management Medical coding SAE consistency verification External data processing Data review report, data management report writing
Statistical analysis: statistical design of clinical protocols, overall design and statistical methods, randomized study on sample size estimation, blinding setting, Statistical Plan (SAP) Creation of analytical databases under CDISC standards Statistical reports
Assist sponsors in designing a complete, full-cycle clinical development strategy — "personalized" clinical development plan and protocol design services based on species characteristics and registration objectives
The scope of Clinical trial recruitment covers healthy subjects, inpatients and outpatients for various indications.
Product market research
Product strategy development
Registration strategy planning
Marketing application
Post-marketing support
New product updates
Overall product development strategy and registration risk assessment
Correlation analysis and risk assessment of BE trial in vitro and in vivo
Clinical development strategy design for innovative and improved new drugs
Consulting and guidance on the practical process of product registration and declaration
Post-market product positioning, re-evaluation and secondary development strategy design for traditional Chinese medicines