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More info about DOKUMEDS

Pharmacovigilance services; Medical monitoring and Medical review

DOKUMEDS

Range of pharmacovigilance services is available covering both clinical and post-marketing safety, tailored to meet customers’ business needs.

  • EudraVigilance (EV): Registration with EV; Responsible person for EV; EVMPD updates; Testing with national Competent Authorities (CAs)
  • AE and ADR handling: Receipt, initial assessment and following up with reporter; Assessment of seriousness, expectedness and causality; Narrative writing; Reporting to Sponsor and entering into Sponsor’s or MAHs safety database; MedDRA coding; Source records maintenance
  • Expedited submissions to CAs: Using EV Web trader or Sponsor’s /MAH safety database and gateway
  • Other submissions: Periodic safety update (e.g. DSURs, PSURs) submission to ECs/PIs/CAs; CIOMS creation; Expedited reports submission to ECs/PIs
  • Standard Operation Procedures preparation and adaptation
  • Pharmacovigilance training
  • Other services (Safety profi le monitoring, Signal detection and review of new data, Risk-bene fit assessment etc.)

 

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