Clinical Operations

Sitero’s experienced team provides comprehensive clinical trial management services to help life science and biopharmaceutical clients discover new treatments for patients.

We enhance the success of trials by leveraging our therapeutic, technical and functional expertise to work collaboratively with our sponsors to ensure we provide an efficient, high quality solution. We have both global and local regulatory knowledge, strong relationships with investigational sites and deep industry expertise that allows us to increase the effectiveness and efficiency of running a clinical program.

Clinical Operations Services

  • Study Feasibility Assessment
  • Study Design
  • Protocol development, review and optimization
  • Investigator Identification & Selection
  • Subject Recruitment and Retention Strategies
  • Enrollment Projections & Management
  • Site Contract & Budget Negotiations
  • Investigator Payment Administration
  • Vendor Selection & Management
  • Clinical Monitoring Plan Development
  • Informed Consent Form Development
  • Trial Master File Creation & Maintenance/Regulatory Document Management
  • Regulatory and Site/IRB Submission Management
  • Investigator Meeting Coordination
  • Risk Management
  • Comprehensive & Risk-based Monitoring compliant with ICH E6 R2
  • CRA Management and Quality Control

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