Vigilare International provides top pharmacovigilance and contact center services, ensuring the most effective safety and risk management solutions for your trial’s needs.

Vigilare’s service solutions result in streamlined operations, allowing your team faster access to safety data, and frees up both your capital and your staff to focus on in depth product safety analysis.

We can provide:

• a state-of-the-art contact center to meet both in-bound inquiry fulfillment and out-bound patient support services.
• direction and management of  large safety and risk management teams
• receiving and processing thousands of adverse event reports
• patient support programs
• medical inquiry contacts         

Vigilare’s unparalleled management team has taken their decades of experiences to develop business solutions and streamlining strategies to ensure regulatory compliant and inspection ready data. 

You may choose either partial or full end-to-end product vigilance services, for any trial ranging from drugs and devices to vaccines, over the counter products and nutraceuticals.

Vigilare’s comprehensive pharmacovigilance solution eliminates the need for additional internal infrastructure

• creation of in house safety processes
• building of product safety databases
• growth and management of large in-house team

Consulting and Quality Assurance Services:

• Inspection Readiness
• QA Audits
• CAPA Creation, Tracking and Management
• GAP Analysis and Suggested Remediation
• Transformational Change Management
• Systems Validation
• Due Diligence 

Medical Information and Product Contact Center:

 Inbound and Outbound- Web and Telephony Services

• Medical Information Inquiry
• Tracking
• Documentation
• Fulfillment
• Adverse Event Contact Intake and Follow-up
• Product Quality Complaint
• Report Tracking
• Transfer
• Patient Outreach
• Patient Contact Programs

Adverse Event Processing: 

• Complete a Partial ICSR Management
  •  Case Receipt and Data Entry
  • MedDRA,  WHO-Drug Dictionary Coding
  • Narrative Writing
  • Quality Control
  • Assessment and Medical Review
  • Submission of Reports to Health Authorities and Stakeholder 
  • Health Authority Liaison

Risk Management and Aggregate Reporting: 

• Periodic Safety update Reports (PSURs/PBRERs)
• Periodic Adverse Experience Reports (PADERs)
• Development Safety Update Reports (DSUR)
• Review of Line Listing
• Signal Detection Activities
• Regulatory Interactions and Product Support
• Risk Management Plans/REMS 

Operational Approaches

Turnkey Pharmacovigilance Processes & Systems

• Fully validated database
• Full set of SOP’s
• All Staffing is provided and managed via Key Performance Indicators
• Detail QA Plan
• CAPA

Staffing Model

Vigilare provides experience pharmacovigilance staff to work within clients system

• ARGUS and/or ARISg experience
• Managed and directed by client’s PV management
• Staff trained on client SOP’s and systems

Hybrid Approach

• Combine Turnkey and Staffing model
• Custom solution based upon client needs