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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.
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us bring you to a safe landing |
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