Comprehensive Signal Management Services

At Navitas Life Sciences, we understand the critical importance of effective signal management in pharmacovigilance. Our team of experienced professionals is committed to supporting your organization’s needs in this vital area. We combine quantitative and qualitative methods with multiple data sources to help you detect, validate, assess, and track signals efficiently using our advanced automated signal tool.

Expertise you can trust

Our team of highly qualified PV experts supported by a dedicated team of healthcare professionals, including physicians, offer comprehensive support that enhances your PV processes and ensures the safety and efficacy of your products. With in-depth safety data analysis using our proprietary, fully validated, safetyREADY® platform and oversight from a QPPV, we ensure adherence to global regulatory requirements.

Customized and Flexible Solutions

We provide tailored solutions to meet the unique needs of both clinical trial and post-marketed products, including innovative and generic drugs. Our well-established procedures and best-in-class technologies offer customizable, flexible, validated, and cost-effective services that align with your organizational goals.

Our End-to-End Signal Management Services include

Signal Detection

Signal Detection

Utilizing advanced techniques and tools to identify potential safety signals promptly
Signal Validation

Signal Validation

Confirming the relevance and accuracy of detected signals to ensure meaningful analysis
Signal Analysis and Prioritization

Signal Analysis and Prioritization

Conducting thorough investigations to prioritize signals based on their potential impact
Signal Assessment

Signal Assessment

Evaluating signals comprehensively to understand their implications and risks
Recommendation of Action

Recommendation of Action

Providing actionable recommendations to address and mitigate identified risks effectively
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In addition, we also offer:

  • Gap Analysis and Data Integration
    Performing a thorough gap analysis of legacy data and ensuring seamless integration with current systems to maintain both data integrity and continuity.
  • Development of Signal Management Procedures
    Creating and refining procedures tailored to your signal management process, ensuring robust and compliant practices.
  • Training and Workshops
    Offering specialized training and workshops to enhance your team's expertise in signal management processes and best practices.
  • Handling Regulatory Recommendations
    Providing expert guidance and support in addressing and implementing regulatory recommendations to ensure compliance and safety.

CASE STUDY

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Delivering End-to-End Global Signal Activity Services

Learn how we collaborated with our client to reduce costs, increase efficiency and compliance, and improve Patient Safety

CASE STUDY

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PV Safety Benefit Risk Management Optimization and Integration

Learn how we developed and implemented a new integrated operating model to harmonize PV processes

CASE STUDY

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Reducing costs, increasing efficiency and compliance while improving patient safety

Learn how we implemented PV best practices through enabling advanced PV automation and streamlining technology

Gain the Navitas Life Sciences Edge

Experienced Team

Experienced Team

Providing expert support throughout your PV processes
Domain Experts

Domain Experts

30+ years as a trusted partner offering strategic advice and improving your PV operations
Bespoke Services

Bespoke Services

Tailoring solutions to your unique needs
Industry-Leading Networks

Industry-Leading Networks

20+ years of unparalleled PV insight and benchmarking
Commitment to Quality and Compliance

Commitment to Quality and Compliance

Maintaining high standards and error-free operations
Global Infrastructure

Global Infrastructure

Delivering flexible and proximity-based solutions

BLOGS

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Strategizing Artificial Intelligence in Regulatory Affairs and Pharmacovigilance

Ensuring patient safety and compliance with global PV regulations is paramount; our robust Regulatory and PV services integrate AI to enhance efficiency and accuracy.
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Showcasing as a knowledge-based full services CRO: Insights on PV and Precision Medicine

At Navitas Life Sciences, we believe in not just advancing the frontiers of pharmaceutical sciences, but also in giving back to society and academia. Read our blog to learn more.
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Combating counterfeit medicines: Insights from Global QPPV

In the fight against counterfeit medicines, the stakes are incredibly high. Counterfeit drugs pose significant threats to public health worldwide, with far-reaching consequences, especially in regions with limited regulatory oversight. At Navitas Life Sciences, we are dedicated to addressing these challenges head-on.

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