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CRO Services
Clinical Development (Phase I-IV)

Phase Ⅰ Clinical Research Unit

DM & Biostatistics

Central Laboratory

 
Central Laboratory

Overview
The Central Laboratory of Shanghai Clinical Research Center Co., Ltd. operates in compliance with the standards of the College of American Pathologists (CAP) and delivers a comprehensive portfolio of professional laboratory services.

Services

Routine Clinical Testing Platform:
Equipped with fully automated biochemical analyzers, automated chemiluminescence analyzers, hematology analyzers, glycated hemoglobin analyzers and other testing instruments, this platform covers biochemical, immunological, hematological and body fluid testing. It provides professional technical support for clinical research targeting hepatitis, endocrine disorders, diabetes, infectious diseases, oncology, metabolic diseases and other therapeutic areas.

Flow Cytometry Platform:
Fitted with BD Canto II flow cytometers, the platform supports cell immunotherapy validation, antibody drug therapy evaluation, conventional small-molecule drug testing, immune profiling and high-throughput screening.

Small Molecule Bioanalysis Platform:
Deployed with high-sensitivity LC-MS/MS instruments, the platform offers bioanalytical testing services for small-molecule pharmaceuticals. The team has independently developed more than 60 sample analysis methods tailored to diverse chemical structures of synthetic drugs, which are applied in clinical operations to support PK and PD studies for investigational new drug clinical trials.

Protein & Cellular Testing Platform:
Equipped with microplate readers, Luminex liquid phase multiplex assay systems, flow cytometers and other testing equipment, the platform performs protein and cellular level testing for clinical research of peptides, fusion proteins, antibodies, ADCs, CAR-T therapies, oncolytic viruses and gene therapies, including PK, PD, immunogenicity and biomarker analysis.

Nucleic Acid Testing Platform:
Outfitted with PCR instruments, sequencing systems and other nucleic acid analysis equipment, the platform conducts nucleic acid-based testing for pharmaceutical clinical trials, including assays for gene copy number, integration sites, vector biodistribution, gene expression levels and genetic variation analysis.

Testing Projects for Metabolic Disease Drug Development:
The laboratory boasts extensive testing experience in metabolic and endocrine research. It delivers testing of key biomarkers for diabetes, thyroid disorders, osteoporosis, obesity and various inherited metabolic diseases.

Quantitative Biomarker Testing for Health Intervention Outcomes:
We provide quantitative and verifiable objective data through testing services covering multiple modules: Early warning screening for chronic diseases and metabolic risks (glucose & lipid metabolism); Endocrine homeostasis and organ function assessment (hormones & nutritional markers); Body composition and anti-aging evaluation (body fat & oxidative stress markers); Advanced functional omics and multi-dimensional analysis (microecology & precision nutrition).

 
 
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Address: 18F, Building A, 380 Fenglin Road (Fenglin International Centre), Xuhui District, Shanghai 200032, P. R. China
Tel: (86) 21 3367 6666 Fax: (86) 21 3367 6373 Email: info@scrcnet.org
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