SAFETY & MEDICAL MONITORING

Southern Star Research can provide Local Safety Reporting services in the countries we operate for clients with no local presence or for small biotechnology companies without the local expertise. We can aid in the development of a Safety Reporting Plan and can provide partial or full local safety reporting service for clinical trials involving pharmaceuticals and medical devices, including:

  • SAE/SADE Review
  • SAE/SADE Narrative Development
  • Medical Coding of Terms and Concomitant Medications
  • Production of CIOMS and/or MedWatch forms for submission to the relevant regulatory authorities and ethics committees.
  • Reporting of SAEs, SADEs, SUSARs, SUDARs as per timeline requirements
  • Dedicated Safety Officer

Southern Star Research can provide a full range of Medical Monitoring services to complement or supplement your internal study capabilities.

Our valuable services available through our medical monitor are:

  • 24/7 Medical Monitoring Coverage
  • Protocol Review and Concept Review
  • Study and/or Therapeutic Area Training of study team / sites
  • Investigator Meetings
  • Patient Eligibility Review
  • Endpoint Adjudication
  • Safety Review Committee Participation
  • SAE Review
  • Writing of Event Narratives for Submission
  • Medical Coding Review
  • General Medical Assistance to Study Sites and Study Team on Medical Queries throughout the study