Study Monitoring

Routine processes brought to perfection through many years of practice, flexibility and openness are the foundation of IST’s approach to monitor research projects from small single-center trials to large multinational studies.

Study preparation

  • CRFs
  • CRF user instructions
  • Investigator handling instructions
  • Patient diaries
  • Investigator files
  • Study master files
  • Plausibility checklists and SDV checklists
  • Feasibility questionnaires
  • Data validation plans
  • Site selection
  • Pre-study visits
  • Organization of investigator meetings
  • Management of investigator contracts
  • Training of investigators and other site personnel

Onsite and in-house monitoring
  • Initiation visits
  • Interim monitoring visits
  • Telephone monitoring
  • Support of study sites
  • Study close-out visits
  • AE reporting to sponsor
  • Medical device malfunction reporting
  • Drug accountability management
  • Query management
  • In-house plausibility checks
  • Calculation of investigator honoraria and patient reimbursements
  • Logistics of study material, support with central readers and laboratories
  • Tracking of expiry dates of study medication
  • Data coding using MedDRA and sponsor-owned thesauri