Linical medical monitors are physicians dedicated to serve as your link to investigators and the project team, helping keep all informed, motivated and productive. Our team of physicians provides expert medical advisory support, consulting and safety monitoring across different therapeutic areas and indications, with a special focus in Oncology.

Our medical monitoring services include:

• Consulting
• Study documents review or development
  • Investigator Brochure,
  • Protocol,
  • CRF,
  • ICF,
  • Statistical Analysis Plan
  • Clinical Study Report
• Training
  • Therapeutic area training
  • Protocol and project-specific safety training at investigators meetings
• Clinical development planning
• Project-specific Medical Monitoring Plan / Safety Monitoring Plan / Safety Reporting Plans according to country-specific regulatory requirements
• Data Cleaning
  • Handling medical queries from sites or ECs regarding appropriate interpretation and application of the study protocol
  • Medical review of data listings
  • Review of medical coding data
• Evaluation of subject eligibility
• Safety
  • Expedited reporting of SAEs
  • AE and SAE logging, tracking, MedDRA and WHO-DD coding, case processing and distribution to stakeholders
  • Individual case safety reports
  • Aggregate report writing
  • Periodic safety updates
  • Development safety update reports
  • Concise safety analysis and benefit-risk evaluation
  • Annual safety reports or clinical safety reports
• Risk evaluation and mitigation strategies