Medical Monitoring & Pharmacovigilance Services

Medical Monitoring

The Medical and Pharmacovigilance Service is headed up by the Chief Medical Officer.

Medical monitoring is provided by a team of experienced Study Physicians, with a robust system of back up in
place to ensure continuous medical cover for all studies. They provide Study Physician services across a broad
range of therapeutic areas and support the project team in terms of protocol training/compliance and therapeutic
area training. Our Study Physicians work with our clients, to enable a successful delivery for all studies, keeping
patient safety at the forefront at all times.

EastHORN Physicians perform the following tasks:

  • Support Feasibility and Site selection
  • Review Core documents (IB, Protocol, ICF, eCRF, Subject Diaries and Subject Card, etc)
  • Provide Protocol training to Sites and Project team members
  • Provide Therapeutic Area training to Project team members
  • Site Management – respond to queries (e.g eligibility) from sites and Project team/CRAs etc
  • Ongoing Safety Data Review, including review of Protocol Deviations
  • Write the Study Specific Medical Plans
  • Review other Study Specific Plans
  • Write Data Monitoring Committee (DMC) Charters and can be a member of DMC
  • Attend all relevant Client/Internal/Site meetings
  • Review all study team deliverables such as Tables, Figures and listings, safety narratives and clinical study reports
  • Provide a robust 24/7 Emergency Medical Cover service via our Call Centre, focusing on Emergency Out of Hours/On-Call service.

Pharmacovigilance

EastHORN offers full range Pharmacovigilance services in clinical studies of all phases:

  • Development of Safety Management Plan specific for each project
  • Protocol review/safety section development
  • Case Report Form review / SAE form development
  • Investigator Brochure review
  • Collection, validation, and follow-up of Adverse Events
  • Medical review of collected data, writing Case narratives, MedDRA coding
  • Providing an E2B compliant safety database for record management, reconciliation with
    clinical database
  • Serious Adverse Event triage, SUSAR report generation
  • Periodic safety reports (DSUR) generation
  • Regulatory submission of expedited and periodic safety reports
  • Registration of the Sponsor and EastHORN PHV personnel with Eudravigilance
  • Providing Responsible Person for Eudravigilance