ABOUT US

The Zhongguancun Shuimu Medical Technology Service Group was established in 2017 and is headquartered in the Beijing Yizhuang Economic and Technological Development Zone. It is committed to accelerating the process of registration and listing of innovative medical device products, and solving the "last mile" problem of industrialization for innovative medical device companies. The Group is the chairman unit of the Clinical Trial Branch of the China Association for Medical Devices Industry, the executive vice chairman unit of the Application Evaluation Branch of the China Medical Equipment Association, and the chairman unit of the Medical Device Committee of the Beijing Pharmaceutical Association.

Company Introduction
Development History
Company Honors
Subsidiary
Team Introduction
Corporate News
Shumuk University

Clinical CRO Platform

Beijing Shuimu Jingchuang Pharmaceutical Technology Co., Ltd. is a Contract Research Organization (CRO) specializing in providing professional clinical research technical services for medical device companies. We primarily offer specialized technical services and one-stop solutions for medical device clinical trials, medical writing, global registration, GMP consulting, and other related services.

Headquartered in Beijing, we have established branch offices in South China, Southwest China, and East China, and have personnel stationed in multiple cities across the country, forming a comprehensive and nationwide service network.

Our team is proficient in various types of clinical trials, registration, and clinical evaluation work before and after market approval. We have participated in the execution and planning of numerous projects and have extensive practical experience. Our team members have collectively served over 3,100 clients and obtained over 1,080 registration certificates.

Our Advantages

  • Wide range

    Radiotherapy equipment/system, medical machine human, IVD, medical good and medical software special numerous transdomain house bacteria more than 90% active passive medical city

  • Extensive Internal and External Resources

    Internal Innovation is a platform with extensive resources in the domestic healthcare industry. It provides one-stop services ranging from clinical trial design and implementation to registration and market access. Externally, it has rich connections in the industry and a deep understanding of the social and commercial aspects

  • Rich project experience

    Assisting in the approval of the first and second domestically produced proton therapy systems, we are currently involved in several heavy ion and proton projects, undertaking over 80% of domestic medical robot projects. We have also assisted clients in successfully launching the first domestically produced total knee replacement surgery navigation system and the world's first intuitive image-guided spinal surgery navigation system

  • High efficiency and fast evidence acquisition

    100% pass rate in inspections by national/provincial authorities

  • Professional compliance

    The team members have an average working experience of more than 10 years and have established dozens of internationally recognized standard operating procedures (SOPs), ensuring compliance and efficiency throughout the clinical trial process. The clinical trial team is one of the largest in the medical device CRO industry, with a presence in major cities across the country, capable of undertaking large-scale clinical trial

  • Delivering excellent quality

    The project operations and company management are both conducted using a digitized and transparent management approach, ensuring traceability and accountability

  • Wide range

    Radiotherapy equipment/system, medical machine human, IVD, medical good and medical software special numerous transdomain house bacteria more than 90% active passive medical city

  • Extensive Internal and External Resources

    Internal Innovation is a platform with extensive resources in the domestic healthcare industry. It provides one-stop services ranging from clinical trial design and implementation to registration and market access. Externally, it has rich connections in the industry and a deep understanding of the social and commercial aspects

  • Rich project experience

    Assisting in the approval of the first and second domestically produced proton therapy systems, we are currently involved in several heavy ion and proton projects, undertaking over 80% of domestic medical robot projects. We have also assisted clients in successfully launching the first domestically produced total knee replacement surgery navigation system and the world's first intuitive image-guided spinal surgery navigation system

  • High efficiency and fast evidence acquisition

    100% pass rate in inspections by national/provincial authorities

  • Professional compliance

    The team members have an average working experience of more than 10 years and have established dozens of internationally recognized standard operating procedures (SOPs), ensuring compliance and efficiency throughout the clinical trial process. The clinical trial team is one of the largest in the medical device CRO industry, with a presence in major cities across the country, capable of undertaking large-scale clinical trial

  • Delivering excellent quality

    The project operations and company management are both conducted using a digitized and transparent management approach, ensuring traceability and accountability

cro服务内容

  • Clinical trials

  • Medical writing

  • Global registration

  • IVD

  • Quality management

Service Case Studies

  • Tumor/Radiation-related Services

    Proton/carbon ion therapy system

    Linear accelerator

    Electron beam radiation therapy system

    Tumor radiofrequency treatment equipment

    Tumor photodynamic therapy device

    Radiation therapy planning software (TPS)

  • Medical Robotics

    Orthopedic surgical navigation and positioning system (knee joint, hip joint, spine, etc.)

    Plasma radiofrequency surgical system

    Cardiac electrophysiology interventional instrument control system

    Active upper limb rehabilitation system

    Pediatric lower limb intelligent rehabilitation system

  • Medical Aesthetics/Skin Care

    Sodium hyaluronate gel

    Poly-L-lactic acid filler

    Recombinant collagen protein dressing

    Scar gel

    Artificial skin

    Plasma skin treatment device

  • IVD

    Colorectal cancer multi-gene methylation detection test kit (fluorescent PCR method)

    Novel coronavirus and influenza A/B virus nucleic acid detection test kit (fluorescent PCR method)

    Microsatellite instability (MSI) detection test kit (fluorescent PCR method)

    FBN1 gene testing product (semiconductor sequencing method, including reagents, instrument, and software)

    Hepatitis B virus surface antigen detection test kit (chemiluminescence method)

    Lung cancer gene mutation detection test kit (NGS method, including reagents and software)

    Congenital hearing loss gene mutation detection test kit (fluorescent PCR method)

    FOLR1 antibody detection test kit (immunohistochemistry method)

    Trisomy chromosome non-disjunction (T21, T18, T13)

    Detection test kit (reverse termination sequencing method)

    EGFR/ALK/ROS1/BRAF/KRAS/HER2

    Gene mutation detection test kit (reversible terminator sequencing method)

    Fat-soluble vitamin determination reagent kit (ultra-high performance liquid chromatography-tandem mass spectrometry method)

    Novel coronavirus antigen detection test kit (colloidal gold method/latex method) (reagents + instrument)

    CYP2C19 and VKORC1 gene testing kit

  • Other Active Medical Devices

    Colorectal cancer multi-gene methylation detection test kit

    Novel coronavirus and influenza A and B virus nucleic acid detection test kit (PCR method)

    MSI detection test kit (fluorescent PCR method)

    FBN1 gene detection product (semiconductor-based assay)

    Hepatitis B virus surface antigen detection test kit

    Lung cancer gene mutation combined detection test kit

    Congenital hearing loss gene detection test kit

    Colorectal cancer multi-gene methylation detection test kit

    Novel coronavirus and influenza A/B virus nucleic acid

    MSI detection test kit (fluorescent PCR method)

    Colorectal cancer multi-gene methylation detection test kit

    Novel coronavirus and influenza A/B virus nucleic acid detection test kit

    MSI (microsatellite instability) detection test kit (fluorescent PCR method)

    FBN1 gene testing product (semiconductor-based assay)

    Hepatitis B virus surface antigen detection test kit

    Lung cancer gene mutation co-detection test kit

    Congenital hearing loss genetic testing kit

    Colorectal cancer multi-gene methylation detection test kit

    Novel coronavirus and influenza A/B virus nucleic acid detection test kit

    MSI detection test kit (fluorescent PCR method)

  • Other Active Medical Devices

    Colorectal cancer multi-gene methylation detection test kit

    Detection test kit for novel coronavirus and influenza virus types A and B antigens

    MSI detection test kit (fluorescent PCR method)

    FBN1 gene testing product (semiconductor-based assay)

    Hepatitis B virus surface antigen detection test kit

    Lung cancer gene mutation co-detection test kit

    Congenital hearing loss gene detection test kit

    Colorectal cancer multi-gene methylation detection test kit

    New coronavirus and influenza A and B virus nucleic acid detection

    MSI detection test kit (fluorescent PCR method)