Welcome to HitGen

Services

Enabling Innovative Drug Discovery with Advanced Technologies

  1. Services
  2. Clinical Operation

Clinical Operation

Our Services

  • Overall study management and execution

  • Provide overall study management and execution, including but not limited to feasibility study, Investigator/site selection, study start-up, subject enrollment and retention, site monitoring, site close-out within the study timeframe and budget.

  • Embed Risk-Based Monitoring concept such as centralized monitoring, specific risk management based on trial design and study phase, to increase the effectiveness of on-site monitoring

  • Pharmacovigilance (ICSR、PUSR、risk management etc.)


Our advantages

  • High quality and compliance with ICH GCP, local regulatory requirement and the relevant standards in project execution

  • Perfect clinical Quality Management System (cQMS),

  • Rich experience in clinical project management

  • Good cooperative relationship with the hospital


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