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PARTNERING FOR SAFETY AT EVERY STEP.

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WHY BIORASI FOR SAFETY & PV?

Safety oversight is more than a requirement — it’s the foundation of trust. As part of our Focused Solutions program, Biorasi’s Safety and PV team work as an extension of your organization, embedding experts alongside your clinical and regulatory leaders to facilitate uninterrupted compliance and clear decision-making.

SERVICE SCOPE

  • Proactive Oversight – 24/7 medical monitoring and continuous risk assessment
  • Global PV Network – Compliance and reporting in 48 countries
  • Integrated Approach – Cross-functional alignment with clinical, data, and regulatory teams
  • Inspection-Ready – 100% audit/inspection pass rate across sponsor programs
  • Post Marketing Capabilities – Supporting your studies at every step.

THE BIORASI ADVANTAGE

Safety Pharma

 

From AE reporting to risk assessment and mitigation, we safeguard your study with rigor, precision, and integrity at every step.

COMPREHENSIVE and Standalone Solutions

End-to-End Safety Management:

  • Use of validated safety databases (e.g., Oracle Argus or sponsors’ platform of choice)
  • Adverse event (AE) / serious adverse event (SAE) case processing
  • Signal detection, evaluation, and risk mitigation · Safety database setup, migration, and management
  • Regulatory submissions (MedWatch, CIOMS, E2B (R3), local formats)
  • Management of post-marketing adverse event reports

Strategic PV Partnership:

  • Medical monitoring and 24/7 site support
  • Development of safety management plans and signal detection strategies
  • Ongoing PV compliance audits and CAPA programs

 

 

FROM OUR PARTNERS