Clinical Operations

Our clinical services span the full spectrum of trial implementation including site selection and qualification, clinical trial management activities and clinical trial monitoring.  Our experienced clinical research professionals lead each trial to ensure a successful study start-up, maintenance and close-out.   We offer clinical services on a stand-alone basis or as part of an integrated “full-service” solution.

Clinical Operations Services include:

  • Protocol Preparation and Review
  • ICF (Informed Consent Form) Preparation and Review
  • Site Identification, Feasibility, Evaluation, Selection, Budgeting & Contracting
  • Investigator and Site Personnel Training
  • Preparation of Study Manuals, Logs and Forms
  • Design Case Report Forms (CRFs), Diaries, Questionnaires
  • Regulatory Document Collection, Management and Tracking
  • IRB (Institutional Review Board) Preparation and Compliance
  • Clinical Activity Status Tracking
  • Source Document Review
  • Subject Recruitment Assistance
  • Adverse Events Tracking/Management
  • Protocol Deviations/Violations Tracking/Management
  • Investigational Product Management
  • Site Data Query Assistance
  • Project Management
  • Medical Monitoring
  • Clinical Monitoring