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. We offer Pre and Post Marketing Pharmacovigilance Services. 

Our services include:

EudraVigilance

  • Registration within the EudraVigilance database (EVCTM)
  • Responsible person for EudraVigilance

Adverse Event (AE) and Adverse Drug Reaction (ADR) handling in clinical trials and Post-marketing

  • Safety Database set-up and maintenance in Clinical Trials
  • Receipt, initial assessment (of seriousness, expectedness and causality) and follow up
  • Local Pharmacovigilance contact person with National Competent Authorities
  • Literature review for Adverse Drug Reactions
  • Narrative writing and reporting to Sponsor and entering into Sponsor’s or MAH’s safety database
  • Source records maintenance

Expedited submissions to Competent Authorities (CAs)

  • Via EudraVigilance
  • Via National Competent Authorities

Aggregated reports and Other submissions

  • Periodic safety update (e.g. Annual Safety Reports (ASR), Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSURs)) submission to Ethics Committees / Principal Investigators / Competent AuthoritiesCommittees / Principal Investigators / Competent Authorities
  • Suspect Adverse Drug 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
  • Development of Safety Management plan and Risk management plan
  • Development of Safety Reporting plan
  • Sales representative safety training
  • Clinical Trial Site personnel training
  • Detailed Description of PharmacoVigilance System

Medical Device Vigilance

  • Set up and maintenance of complete MDV system
  • Collection, investigation, and assessment of medical device incidents
  • Medical device incident reports submission to Competent Authorities
  • Medical device incidents records maintenance
  • Development of Periodic Summary Reports