Safety Comes First

Dokumeds has an extensive background in managing all aspects of drug safety and pharmacovigilance monitoring. Phamacovigilance during a clinical study is integrated into our study service, with the appropriate specialists assigned based on services contracted. For individual services, or a comprehensive safety program, Dokumeds can help.

Our services include:

EudraVigilance

  • Registration within the EudraVigilance database (EVCTM)
  • Responsible person for EudraVigilance
  • EudraVigilance Medical Production Dictionary updates (EMPDU)

Adverse Event (AE) and Adverse Drug Reaction (ADR) handling

  • Receipt, initial assessment and follow up with reporter
  • Assessment of seriousness, expectedness and causality
  • Narrative writing
  • Reporting to Sponsor and entering into Sponsor’s or Marketing Authorization Holder's (MAH's) safety database
  • MedDRA coding
  • Source records maintenance
  • Literature review for adverse drug reactions

Expedited submissions to Competent Authorities (CAs)

  • Using EudraVigilance Webtrader (with or without safety database, in E2B format)
  • Using Sponsor’s / MAH safety database and gateway

Other submissions

  • Periodic safety update (e.g. Annual Safety Reports (ASRs), Periodic Safety Update Reports (PSURs), submission to Ethics
  • Committees / Principal Investigators / Competent Authorities
  • Suspect Adverse Reaction Reports (CIOMS) creation
  • Expedited report submission to Ethics Committees / Principal Investigators

SOPs, Documentation and Training

  • Development and Adaptation of Safety SOPs
  • Development and Adaptation of training materials
  • Personnel training
  • Risk management plan
  • Detailed Description of PharmacoVigilance System