End-to-end Multivigilance Safety Services

Wipro is a frontrunner in the field of Multivigilance, owing to its advanced and robust end-to-end system, which is reinforced by its team of accomplished scientific and medical experts.

Our team can support pharmaceutical and Biopharma companies throughout the entire process, from clinical trial operations to collecting data after obtaining market authorization, while adhering to regulatory and quality standards. We leverage efficient tools to ensure that the data is properly collected and used for creating various safety documents.

Given the extensive requirements of Multivigilance and the high maintenance cost of resources and infrastructure, Wipro provides the related solutions required for scaling up, including the use of cutting-edge technology, and ensuring on-time reporting. By enhancing compliance and streamlining the processing of safety data, our services are enabling companies to achieve greater efficiency and lower costs.

Wipro has a specialized unit comprising medical professionals who are proficient in managing case processing and compliance activities, as well as creating various aggregate reports based on therapeutic areas. Additionally, this unit also handles the submission of reports to regulatory bodies.

Wipro’s extensive portfolio of Multivigilance services

Safety Surveillance

• Setting up a safety system for Multivigilance
• Setting up safety database: Validation, implementation, data migration, etc. as per 21-CFR-part 11 requirements
• Case processing: Intake, data entry, medical coding, narrative writing, etc.
• Regulatory submissions: Electronic and/or manual submissions
• Optimization of existing safety system
• Reconciliation
• Medical writing: PADER, PSUR (R1), PBRER (R2), DSUR, CAR, CPSR, local formats, etc.

- Aggregate report authoring
- Review & finalization
- Document publishing & submission

• Risk Management: Signal management, RMP     

Quality Management System

• Provisioning of local responsible person
• Preparing and maintaining the Pharmacovigilance System Master File (PSMF)
• SOP reviewing / writing
• Preparing and maintaining Safety Data Exchange Agreements (SDEAs)
• Conducting system audits
• Preparing for regulatory inspections
• CAPA Management

Nutra-vigilance
Food supplements vigilance services:

• Managing and reporting adverse events
• Preparing summary reports
• Nutra-vigilance SOPs preparation/review

Materiovigilance
Medical devices vigilance services:

• Preparing technical dossiers
• Evaluating and managing materiovigilance incidents
• SOPs preparation/review
• Preparing/reviewing contracts (vigilance clauses)
• Liaison with the Authorities
• Regulatory assistance

Cosmetovigilance
Cosmetic products vigilance services:

• Evaluating and monitoring of cosmetic complaints related to marketed products
• Evaluating undesirable effects
• Reporting of undesirable effects or product safety-related issues
• Safety assessments including Cosmetic Products Safety Reports (CPSRs) for EU compliance
• Services of a responsible person

Talosafe - Wipro’s IP for Automation 

Wipro has developed a unique PV Automation Service Platform called TaloSafe for achieving a complete, correct, and compliant output through a global delivery model. 

This enables pharmacovigilance operations teams to ensure clinical and compliance corrections of cases.

TaloSafe includes intelligent automation driven by, RPA, Artificial Intelligence, Proprietary Workflow Engine, and Operations Management Systems that enable Pharma companies to customize processes and metrics to their client’s specifications. The framework also lets them track the process, monitor metrics, and extract meaningful reports.