Clinical Trial Services

Sygnet Research > Clinical Trial Services

CLINICAL TRIAL SERVICES

Supporting clinical program at any phase or every phase – on the drug development continuum

Trial monitoring

  • Investigator Identification and Site selection
  • Site Qualification
  • Site Initiation and Site staff Training
  • Interim and Routine Monitoring Visits
  • Ensuring subject safety and regulatory compliance
  • Source data verification and CRF data review
  • Monitor Adverse Event reporting
  • Ensure regulatory compliance
  • Close Out Visits

Project Management

  • Project Plan development, Feasibility assessment, Investigator and Site selection
  • Study set-up and site start up
  • Organizing Investigator Meetings and Site training
  • CRA resourcing, mentoring, co-monitoring support and monitoring report review
  • Third party vendor management
  • Managing study supplies and clinical site payments
  • Managing sponsor communications
  • Ensure the trial team performance is compliant with all applicable regulatory requirements, project-specific SOPs and industry best practices
  • Managing client expectations for on-time and on-budget performance

Regulatory and medical writing support

  • Protocol and related document management
  • Clinical Study Reports (CSRs)
  • Safety Reports