We specialize in providing end-to-end biometrics support and clinical trial management through flexible Functional Service Provider (FSP) and Resource Process Outsourcing (RPO) models. dd a description about this category
We deliver data packages that are "submission-ready" for the FDA, EMA, and NMPA.
Study Design: Protocol development, sample size calculation, and randomization.
Statistical Analysis Plans (SAP): Comprehensive planning, including Mock TLFs.
CDISC Implementation: Expert conversion of raw data into SDTM and ADaM datasets.
Output Generation: High-fidelity Tables, Listings, and Figures (TLFs) for Clinical Study reports (CSR).
Leveraging our deep network in China, we facilitate localized clinical operations with global standards.
Data Management: EDC setup, data cleaning, and dictionary coding (MedDRA/WHODrug).
Regulatory Navigation: Strategic consulting for multi-regional clinical trials (MRCTs).
Site Management: Efficient trial monitoring and patient recruitment via our partner network.
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