Pharmacovigilance & Medical Monitoring

Pharmacovigilance

EastHORN offers Pharmacovigilance support in clinical studies of all phases. Our safety team is highly experienced in the collection and evaluation of safety data and in safety reporting throughout Europe.

The Pharmacovigilance services that EastHORN offers are:

  • Collection and validation of safety data;
  • Medical evaluation of safety data;
  • MedDRA term coding;
  • Maintenance of the safety data filing system;
  • SAE/SUSAR reporting;
  • Medical review of laboratory test results;
  • Preparation of periodic safety reports;
  • Registration of sponsor into the EudraVigilance system;
  • Outsourcing of Pharmacovigilance personnel.

Medical Monitoring

Our expert medical monitoring staff aides the project team with a better understanding of the study hypothesis, inclusion and exclusion criteria, and procedures. Our monitors act as clinical trial methodologists so that project teams carry out clinical research projects precisely in every therapeutic area.

EastHORN medical monitors can:

  • Train the study center team;
  • Address investigators’ questions;
  • Review key documents including protocols, clinical study reports, case report forms (CRFs), and off data analysis;
  • Review all study team deliverables such as final narratives or clinical study reports;
  • Serve as medical directors to sponsors who do not have their own staff.