Against the advancement of global pharmaceutical innovation, China has become a key region for international multi-center clinical trials thanks to its large patient pool, diverse disease spectrum, and improving clinical research infrastructure. Overseas sponsors face divergent regulations, complex hospital structures, and cross-departmental coordination challenges. With 17 years of SMO experience, MedKey Clinical helps global clients efficiently access China’s clinical research resources. Founded in 2009, MedKey Clinical employs over 5,300 professionals, operates in 150+ cities and 1,200+ large hospitals, and includes 5,000+ frontline CRCs and supervisors plus 160+ project managers. The company has executed 4,900+ clinical trials, supported enrollment of 280,000 patients, completed 790,000+ study visits, passed inspections by NMPA, FDA, EMA, and PMDA, and contributed to 370 new drug approvals.
As an SMO, MedKey’s CRC teams act as critical liaisons: engaging regulators and ethics bodies (NMPA, IRB/IEC, HGRAC) to ensure compliance; coordinating sponsors, CROs, and hospital stakeholders (investigators, nurses, pharmacies, labs, imaging, pathology) to streamline in-hospital processes; and managing subjects to protect rights and safety, improving enrollment and follow-up efficiency for overseas clients. To ensure quality, MedKey has a standardized training program: basic GCP within one month, core CRC competencies within three months, continuous on-the-job training, and biennial advanced GCP retraining to align with international standards. A two-tier QA/QC system covers the full project lifecycle with document control, independent audits, KPI monitoring, and risk assessment to meet global regulatory requirements.
Powered by a CTMS, MedKey integrates de-identified data from 18,500+ investigators and 280,000+ patients to support project management, risk evaluation, and resource allocation, enhancing transparency and efficiency. MedKey provides one-stop services including Study Start-Up (SSU), on-site execution (CRC/FSP), patient management, quality audits, digital tools (EDC/ECOA/IRT), automated SUSAR reporting, Real-World Studies, and healthcare big-data research for end-to-end operational support.
Leveraging mature industry experience and efficient execution, MedKey Clinical connects global clients with high-quality Chinese sites and abundant patient resources to accelerate development and commercialization of innovative medicines.