Client Associated Businesses, Inc.

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PHARMACOVIGILANCE

(THROUGH PHARSAFER PARTNER ALLIANCE)

 

AE CASE MANAGEMENT SERVICES:

  • Processing of individual Case Safety Reports (ICSRs) originating from various sources
  • Post-marketing non-solicited reports/Spontaneous reports
  • Clinical trial reports
  • Special reports (Legal, Literature and E2B)
  • Triage and tracking all cases
  • Initial and final regulatory assessments
  • MedDRA and WHO-drug coding
  • Medical narrative
  • Development and maintenance of Analysis of Similar Events
  • Complete medical monitoring and follow-up support
  • Processing of expedited ICSRs to regulatory authorities

 

REPORTING SERVICES:

Periodic Post-marketing safety reports:

  • PSUR (6 months, annual or 3-year in accordance with Volume 9A, GVP, Schedule Y)
  • Summary Bridging Report Addendum
  • PADER (annual or quarter reports in accordance with 21CFR 314.80 (c) 2)

Periodic clinical trials related safety reports:

  • ASR/DSUR
  • Semi-SUSAR Ad hoc safety reports
  • Clinical Overview for labeling update
  • Safety expert report for assessment of safety queries

Other reports:

  • Safety summary
  • Customized line listings for aggregate data

 

LITERATURE SCREENING SERVICES:

  • Specialists with vast subject matter expertise and domain centric knowledge
  • Extensive worldwide literature search in peer-review journal databases and medical databases
  • Knowledge and adherence to global regulatory requirements and compliance
  • Review of articles/ abstracts for inclusion in ICSR, PSURs and other specialized reports  

 

SPECIALIZED SERVICES:

  • Risk Management Plans (RMPs) and Updates including REMs
  • EU QP PV/Deputy Services
  • Signal Detection activities
  • Auditing and Inspection Readiness preparation
  • Training for all staff on Pharmacovigilance
  • Safety Data exchange agreements and maintenance for partners
  • DSMB Management
  • Due Diligence & Integration (incl. SOP writing)
  • Safety Database Implementation & Upgrades/maintenance
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