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Post-Marketing Surveillance

Real-World Insights Beyond Approval


Focuses on continuous safety and efficacy monitoring once your product enters everyday clinical use. By capturing real-world patient experiences, you gain invaluable data to refine labeling, address rare adverse events, and sustain regulatory compliance over the long term.

Key Post-Marketing Services

Phase IV & Observational Studies

  •  Detect rare or longer-term side effects not always visible in pre-approval trials.
  • Use real-world data to refine understanding of product performance.

Product Registries & Longitudinal Tracking

  • Maintain ongoing databases to capture patient outcomes, safety signals, and treatment adherence.
  • Combine registry findings with broader public health data for a holistic view.
  • Risk Minimization & Communication
  • Translate PMS findings into safety updates for healthcare professionals and patients.
  • Develop clear, data-driven communication strategies to manage risks proactively.

Regulatory Reporting & Lifecycle Management

  • Fulfill local and international post-approval documentation requirements
  • Strengthen product credibility through transparency and timely risk mitigation.

 Beyond the Launch: Thriving in a Real-World Setting

Even the most thoroughly tested products face new variables once they reach everyday clinical environments. Our specialized Beyond the Launch framework goes further than routine PMS: 


 Adaptive Safety Monitoring

  Continuously refine safety signals to reflect evolving patient demographics, off-label uses, or comorbidity profiles.



  Rapid Response Strategies

 Deploy targeted interventions quickly when new safety concerns arise, ensuring minimal disruption to patient care and public trust.


Multistakeholder Engagement 

Collaborate with clinicians, pharmacists, payers, and patient advocacy groups to gather diverse insights and feedback.

By embracing these extended strategies, Kernel helps you keep pace with real-world shifts, maintain high-quality care for patients, and preserve the long-term viability of your product.