Affiliate Services

CONTINUUM offers safety services to Affiliates/Local Operating Companies in various countries across single cases, aggregate reports and literature:

  • Mailbox management on behalf of the affiliate

  • Case Intake, receipt, triage, case creation & acknowledgements

  • Adverse Drug Reaction form creation

  • Manual upload of ICSRs & data entry  into non-E2B HA database

  • Local language, social media & Health Authority ICSRs

  • Compliance monitoring

  • Writing PSURs/PBRERs and other aggregate reports for regional/local HA (like Monthly reports for Israel, Annual Safety Report for South Africa, etc.)

  • Generation of line listings from Safety Database for local HAs

  • Local and non-indexed literature screening and review – in English as well as local languages

  • Developing, tracking & reconciliation tools for affiliate activities

  • Maintaining database of local products and local SPC/label management

  • Analysis of gaps in local labels (SmPCs/PIs/PILs) and impact of safety assessment due to missing information in local labels

  • Translation services for CIOMS/narratives/ICSRs & other safety data

  • Training of local affiliates

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