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Case handling within Pharmacovigilance

Our staff has several years of experience within adverse events processing and is trained in using e.g. ARISg and Eudravigilance EVWEB.

We offer a cost effective solution to host your safety data in our database, thereby eliminating your need for expensive installations and set up in-house. We offer efficient management of pre- and post marketing cases.

Clinical trial SAEs can be handled on a trial by trial basis. By using our database we offer consolidation of all SAEs throughout a clinical trial programme ensuring effective monitoring of trial programme safety, complete Development Safety Update Reports and compliance with GCP.

We have a SOP system in place, but we are flexible and ready to tailor our practice to your specific requirements.

Our case processing service may include any or all of
  • Reciept
  • Assessment and triage
  • Coding
  • Data entry
  • Quality control
  • Medical review
  • Follow-up
  • Expedited reporting
  • Reconciliation
Our experienced and trained staff ensures that expedited reporting meets regulatory requirements, whether electronic or in hard copy.
A-consult a/s
Gladsaxevej 3821
DK-2860 Søborg
Denmark

Tel: +45 38330080
Fax: +45 38330280
a-consultata-consult.dk

 
 
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