Affiliate Services

Overview

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 & acknowledgments
  • 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

Our Services

Dedicated Customer Teams & Agile Services

Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.