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Services
Post Marketing Pharmacovigilance
- 24x7 Customer Call receipt & Triage
- Call receipt 24X7
- Call triage
- Call routing to appropriate stakeholder
- Call information capture in database
- Call management
- Forward integration with case processing services
- ADR/ADE case processing & reporting
- Data entry into validated electronic database including historic safety data
- Quality control
- Medical review, narrative writing, MedDRA coding
- Reporting: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.)
- Periodic ADR/ADE Reporting (PSURs/PADERs)
- Complete PSUR/PADER generation
- Formats: ICH E2C, Volume 9a, US FDA 21 CFR Part 314.80, Schedule Y
- Literature searches
- Generation of case narrative
- Product Quality Complaints (PQC) Management
- Call receipt 24X7
- Management of complete cycle from receipt of complaints to response to complainants
- Complaint processing into database
- Complaint distribution to Quality Assurance locations and follow up for analysis report
- PQC reconciliation
- Medical analysis of complaints
- Medical Inquiries Management
- Call receipt 24X7
- Management of standard and off label customer inquiries
- Management of complete cycle from receipt of inquiries to response
- Capture of inquiries in database
- Electronic Safety Database Validation
- Validation plan preparation
- End to end validation activities
- Post ‘Go live’ support
- Safety Data Exchange Agreement Management
- Drafting SDEAs customized per global regulatory requirements
- Review of SDEAs
- Exchange of ADRs with business partners after execution of SDEA
- Signal Detection- Benefit Risk Evaluation
- Causality and Medical assessment, statistical analysis
- Risk Management Plans/Programs
- Writing Risk Management Plans as defined in the Template for EU RMP (Doc.Ref. EMEA/192632/2006)
- Literature monitoring for ADR/ADE
- Ongoing, weekly literature monitoring for identification of ICSRs (Individual Case Safety Reports)
- Active ingredient specific – alternative names/ Product specific
- Integration with case processing in safety database
- Full text articles procurement
- Training of company employees on ADR/ADE reporting
- Pharmacovigilance specific trainings for pharmacovigilance department
- Training on pharmacovigilance for company employees including medical representatives
- Global Compliance monitoring and audits
- Review of company’s compliance data on monthly basis
- Pharmacovigilance audits and recommendations
- Inspections Management
- Support for management of inspections by global regulatory authorities
- Support for CAPA execution for closure of inspection findings
- Department restructuring, turnkey operation
- SOP development
- Recommendations for pharmacovigilance department designing and development
- Recommendations for improvements in the existing pharmacovigilance systems
Pre-authorization (Clinical Trial) Pharmacovigilance
- End to end SAE management services
- 24 x 7 Call receipt & Triage
- Processing of SAEs & electronic reporting
- Causality assessment
- Annual Safety Reports
- Clinical Trials Safety Data Management
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