Focusing on Clinical Research Services, Covering Full-Chain Solutions Including SMO Site Services, Audit & Quality Control,Study Start Up Services,Evidence-Based Medicine Services, and Intelligent Clinical Research.
MedKey Clinical operates across more than 1,300 hospitals in 160 Chinese cities, establishing strategic partnerships with over 50% of these sites through deployment of 5,400+ Clinical Research Coordinators (CRCs) at designated investigator sites. Our partner ecosystem includes the world’s top 20 pharmaceutical companies, China’s top 10 domestic pharmaceutical leaders, over 300 innovative biotech firms, and the global top 10 CXO providers.We deliver efficient, high-quality clinical trial services backed by outstanding regulatory approval performance.This strength establishes us as a premium long-term partner for innovative drug developers, CROs, and nearly 100 leading research hospitals worldwide.
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A robust quality and regulatory compliance system is fully established, with dozens of audits, regulatory inspections and vendor assessments conducted annually. The Company has built a dedicated audit and quality control team to deliver comprehensive quality assurance services for clinical trials, safeguarding the accuracy, integrity and full regulatory compliance of clinical trial data throughout the entire research lifecycle.
Established in 2015, our SSU team comprises more than 200 professional talents, covering service outreach across over 110 cities and 700 research centers. We deliver a full spectrum of standardized services, including pre-project training, site feasibility surveys and evaluations, clinical site activation, preparation and filing for ethics committee submissions, as well as the drafting, submission and follow-up management of clinical trial site agreements. Our scope also encompasses document collection and application preparation for submissions to the Human Genetic Resources Administration of China (HGRAC). Furthermore, we independently provide dedicated services for site activation and professional HGRAC submission applications.
Our services cover the entire lifecycle of clinical research, empowering the research and development of pharmaceuticals and medical devices, advancing the progression of evidence-based medicine, and accelerating product commercialization. We deliver customized full-process project operation strategies for clients, alongside comprehensive full-chain professional services that extend from study design through to the final implementation of research outcomes.
We provide full-process medical affairs services, including protocol drafting, investigator’s brochure compilation, and medical literature retrieval.
We conduct comprehensive assessments on core indicators such as site enrollment capacity, historical project operational data, and department professional strength.
We deliver integrated pharmacovigilance management covering full scenarios: clinical trials, post-marketing safety studies, and investigator-initiated trials (IITs).
We formulate customized plans that integrate core modules covering project governance, quality management, communication coordination, financial management and risk management.
We offer end-to-end data management services throughout the workflow, including data validation, query resolution, data cleaning, medical coding and statistical analysis.
We provide comprehensive academic publication services, including manuscript writing, journal selection and submission, and response to revision requests.
Full-Scenario Coverage · Full-Process Empowerment · Full-Chain Compliance We reshape the new paradigm of clinical research leveraging digital technologies, covering the entire workflow including clinical research design, initiation, execution, data management and regulatory compliance submission, to deliver comprehensive, integrated services for all clinical research projects.
A full-lifecycle electronic data capture and management system compliant with ICH-GCP standards
A compliance tool enabling automated and intelligent SUSAR submission across the entire process
A digital platform covering comprehensive patient lifecycle follow-up and management
A full-chain randomization and drug management solution compliant with ICH-GCP standards
An integrated decision-support platform built on multi-source clinical research data
A vertical industry service platform built for pharmaceutical and medical device companies and clinical research institutions
