Overview
CONTINUUM offers safety services to Affiliates/Local Operating Companies in various countries across single cases, aggregate reports and literature:
Pharmaceutical Affiliate Programs
- 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.