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Services » Clinical Operations

We ensure Clinical Operations services, by training the site teams after the early steps of post-approval, to the last communication to entities regarding the End of Study reporting. Our goal is to make sure every site team works within the regulatory requirements, closely accompanying and supporting every site’s progress and activities.

We strive to guarantee that each site reaches their proposed goals within the project, being attentive and flexible to resolve any unforeseen situation as rapidly as possible, using clear and streamlined communication between every stakeholder in every stage of the process.

Our Clinical Operations services

  • Local project management
  • Communication with sites and entities
  • Site Monitoring Visits
  • Documentation management
    • Ongoing study documentation
    • Protocol amendments
    • Financial agreement amendments
  • Quality Control activities
  • Support to Pharmacovigilance team
    • Safety reporting
  • Support to Data Management team
    • Discrepancy management (queries resolution)
  • Close-Out Visits
  • End of study communication with sites/entities