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Management of Individual Case Safety Report (ICSR)


Pharmacons offers case processing staff that can serve as an extension of your team, following your standard operating procedures, so that you can always manage fluctuation in case volume. Our Specialists have expertise in case processing from clinical trials to post-marketing sources, literature and observational studies. Our focus is on quality of data entered into the safety database in order to ensure that your safety data set is processed consistently and according to international standards.

Our services:

  • Remote processing in client’s database
  • Experience with ARGUS™, ARISg™, and BaseCon
  • Complete or partial processing from all sources
  • MedDRA coding
  • Medical review and assessment by experienced medical team
  • Quality control
  • Follow-up request, tracking, and documentation
  • Reconciliation with business partners
  • Reporting requirements review and tracking of safety regulatory intelligence


How we do it?

OUR PROCESS



Listen to You


Understanding your needs, your objectives and your restrictions are key elements to tailor made solution we will provide you with


Shape the Project Team


Once we have a clear view of the services required, we will allocate the right experts and a dedicated project manager to ensure a lean and efficient collaboration


Deliver high quality compliance


Our focus on quality, combined with the in-depth expertise of our specialists are the pillars for our long-term strategy to ensure your high standards are met and maintained

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Specialist Support Outsourcing

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