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Safety Reporting - Vigilance - QbD Group (1)

Safety Reporting & Signal Detection

Comprehensive safety reporting tailored to your needs

Safety reporting is a critical component of pharmacovigilance and post-marketing surveillance. At QbD Group, our One Vigilance services compile, analyze, and deliver safety reports that ensure compliance with global regulatory requirements. Whether it’s IND Annual Reports, Clinical Study Reports, or NDAs, we provide accurate and timely insights to enhance product safety and regulatory success.

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What is safety reporting?

Safety reporting involves the periodic collection, analysis, and submission of safety data from multiple sources. These reports provide a holistic view of a product’s safety profile and are essential for ongoing regulatory compliance and risk mitigation. Key types of safety reports:

  • IND Annual Reports: Documenting safety information from clinical trials for investigational drugs.
  • Clinical Study Reports (CSRs): Comprehensive summaries of clinical trial data.
  • New Drug Applications (NDAs): Safety data submitted for regulatory approval of new drugs.
  • Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs): Post-marketing safety evaluations.
  • Development Safety Update Reports (DSURs): Ongoing assessments during clinical development.
  • Signal detection: Comprehensive signal management - from data collection to regulatory reporting - delivering actionable insights for proactive risk mitigation.
The value of safety reporting
Safety Reporting - Vigilance - QbD Group (2)

Why is safety reporting essential?

Safety reporting is fundamental to ensuring product safety and regulatory compliance. Here’s why it’s indispensable:

  • Regulatory adherence: Meet global reporting requirements and avoid penalties or delays.
  • Risk management: Identify and address emerging safety signals early.
  • Product confidence: Provide stakeholders with clear evidence of a product’s safety and efficacy.
  • Streamlined processes: Efficiently manage and submit comprehensive safety data.
  • Timely risk identification: Early detection of potential safety issues prevents escalation and reduces harm.
How we support you

How can we help?

QbD Group’s safety reporting services leverage advanced methodologies, including the PSO/ACO classification approach, to deliver precise and actionable insights. Here’s what we offer:

Report compilation and delivery

Report compilation and delivery

IND Annual Reports, CSRs, NDAs, PSURs/PBRERs, and DSURs tailored to meet your regulatory needs.

Advanced methodologies

Advanced methodologies

Utilizing PSO/ACO for classification and rule discovery to optimize post-marketing surveillance.

Regulatory expertise

Regulatory expertise

Ensure alignment with EMA, FDA, and other global authorities.

Comprehensive solutions

Comprehensive solutions

From data analysis to report submission, we manage the entire process.

Custom workflows

Custom workflows

Tailored reporting strategies that align with your operational goals.

Expert risk management

Expert risk management

Evaluating and classifying signals to determine their clinical significance.
Aggregate Safety Reporting - Vigilance - QbD Group (3)

Why partner with QbD Group?

Choosing QbD Group for safety reporting ensures:

  • Expert knowledge: Decades of experience in pharmacovigilance and regulatory compliance.

  • Innovative approaches: Advanced methodologies like PSO/ACO for superior safety data analysis.

  • Seamless service: End-to-end support from data collection to regulatory submission.

  • Proven track record: Successful delivery of safety reports for a wide range of products and markets.

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Looking for expert support in safety reporting?

With QbD Group, you gain a trusted partner who ensures compliance, streamlines your reporting processes, and provides actionable safety insights. Reach out today to see how we can assist you.

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