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Medical Safety/Pharmacovigilance

Because patient safety deserves expert focusMedical Safety and Pharmacovigilance

When medical safety expertise is critical and in-house capacity is limited, we serve as a trusted extension of your team—bringing the leadership, scale, and judgment needed to move programs forward with confidence.

Phase 1/2:

Proactive signal detection, risk characterization, risk mitigation strategies, and communication..

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  • Establish medical safety strategies
  • Regulatory safety strategies
  • Safety portions of the target product profiles, study protocols, IBs, dose justifications
  • Proactive safety monitoring and communication
  • Drug monitoring committees
  • Signal detection, risk mitigation strategies and implementation
  • Aggregate reports
  • Product profile for expanded indications
  • Risk characterization,  mitigation strategies, and implementation
  • Marketing authorization application submissions
  • QPPV
  • Epidemiology

Phase 3/Post-Authorization

We drive Phase III and post-approval safety oversight that de-risks development, satisfies regulators, and protects patients.

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  • Continuous risk characterization, mitigation strategies, and implementation
  • Independent drug monitoring committees
  • RMPs, CCDSs, prescribing labels

Pharmacovigilance

We drive global, inspection-ready safety across Phase III and post-approval—combining compliant case management, blinded oversight, strong governance, and rapid regulatory response to de-risk development and enable your science to scale with growth.

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  • Pharmacovigilance Agreements
  • Case processing, reporting, and oversight
  • Quality and training
  • KPIs

  • Processes for respective functions, implementation, and continuous oversight

  • Ensure compliance with local regulatory requirements at each phase

  • Regulatory authorities inquire responses

  • Blinding processes for case processing and reporting, and oversight
  • PSMF
  • Expand capabilities for large-scale Phase 3 studies

Our teams combine strategic insight with hands-on execution to deliver medical safety solutions that support confident decision-making, regulatory success, and sustainable product growth.

Connect With Our Team TodayAdvance Your Drug Program
with Confidence

Start building reliable, high-quality drug development programs today.

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