Our services

Pharmacovigilance Unboxed

ClaroPV offers comprehensive and proficient support for pre-approval and post-market Pharmacovigilance (PV) and Medical Information (MI) services across various categories of medical products, including pharmaceutical drugs (both brand and generic), biologics, radiopharmaceutical drugs, natural health products, and medical devices.

ClaroPV Services Inc. - A hand with a raised index finger touching a holographic medical cross icon on a transparent screen.

Pharmacovigilance and Medical Information System Set-Up

  • PV system Set-up

  • Call Center Set-up

  • Development/Review of SOPs

  • Development/Review of Pharmacovigilance Agreements

  • Design of Pharmacovigilance Training Program

Quality and Compliance

  • GVP Audits of Vendors/Third-Parties

  • Self-Inspections

  • Regulatory GVP Inspection Readiness

  • Gap Analysis

  • Regulatory Agency Inspections & GVP Audits Assistance

  • Deviation and Corrective And Preventive Action Support

Case Management

  • ICSR Intake and Databasing

  • Medical Review of ICSRs

  • Expedited Reporting

Environmental scanning

  • Local and Global Literature screening and review

  • Canada Vigilance Adverse Reactions Online database screening

  • Foreign Actions Monitoring and Assessment

Medical Device Vigilance

  • Incident Reporting

  • Foreign Action Screening

  • Summary Reports and Issue-Related Analysis

Risk Management Planning & Signal Management

  • Risk Management Planning (EU RMP, Canadian RMP Addendum, REMS)

  • Development of Educational Materials, Surveys and Other Risk Minimization Measures

  • Signal Detection and Management

Medical Information Call Center

  • 24/7 multilingual call center

  • Call intake and follow-up

  • Creation & Maintenance of FAQs and Standard Response Letters (SRLs)

Aggregate Reporting

  • Aggregate Reports (PSUR E2C R1, PBRER E2C R2,  Non-ICH formats, PADER)

  • Issue-Related Summary Reports

  • Benefit-Risk Assessments