Pharmacovigilance

Theradex has over 30 years experience in providing safety services for cancer drug development and is the right choice to assist your company to implement a globally compliant pharmacovigilance (PvG) system. At Theradex we have a team of PvG worldwide experts who can provide a complete range of services using the latest state-of-the-art technology including the Argus Safety Suite.  These services are based on a fully electronic platform which is compliant with the International Conference of Harmonization, ICH–E2B (EU) and 21 CFR part 11 (US-FDA) regulatory requirements and European Medicine Agency (EMA) Guidelines on Good Pharmacovigilance Practices in the European Union.  Theradex also prepares periodic safety update reports, annual safety reports, risk management plans, responses to regulatory authority queries, and any other safety-related documents for your Investigational Medicinal Product.

Theradex is well equipped to help you with evolving PvG challenges, including risk management and signal detection. Theradex can also assist in the establishment of Data Monitoring Committees (DMCs).  Their functional make-up and activities will be tailored to match the requirement of the clinical study phase, from in-study cohort safety review committees (SRCs) to Independent Data Safety Monitoring Boards (IDSMBs) for randomized studies. Theradex can help recruit committee members, develop charters and provide data for support the function of these IDSMBs that safeguard the interests of trial participants, assess the safety and efficacy of the interventions during the trial, and monitor the overall conduct of the clinical trial.

Our PvG experts can work with you to provide the level of services you require to include the following:

  • Consultancy
  • Training
  • SOP Development
  • Safety Plan Development
  • MedDRA Coding
  • Medical Monitoring
  • Legacy Data Review and Transfer
  • Whole Safety Database Setup
  • Validated Safety Database
  • Reconciliation Between Clinical Database and Safety Database
  • Electronic Reporting (E2B) via EudraVigilance (EVWEB)
  • Measuring Regulatory Compliance
  • Responsible Person for EudraVigilance
  • Development Safety Update Report (DSUR) Preparation and Submission
  • Global Literature Search & Review in Support of the DSUR
  • DMC Recruitment and Maintenance