Clinical Research Services
Clinical Research Services
Chengdu Runze Pharmaceutical Technology Development Co., Ltd. is the clinical service center of BociMed, which is a professional Clinical Research Organization(CRO), providing clinical research services for drugs and medical devices. With our own data management and statistical analysis company, it can realize the whole process service from medical protocol, clinical operation, to data management and statistics.
    • 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

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