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.
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
- 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
EastHORN also provides full range postmarketing Pharmacovigilance services for marketed medicinal products.