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