End-to-end support throughout RBQM transformation

We deliver functional services that complement Cyntegrity’s integrated MyRBQM Portal technology with our deep clinical research expertise and managed services.

Our FSP model will help facilitate the implementation and change management process to be as effective and streamlined as possible.

Our SMEs also assist in the development of GxP artifacts and business processes, which will identify any elements that are missing, to better define a risk-based strategy for:

  • Adaptive Monitoring including monitoring plans
  • Centralized Monitoring
  • Study or site-level metrics and Risk Indicators (KRI) selection
  • Deep-dive review of sites
  • Guided decision-making on potential issues

  • Study protocol risk assessment & mitigation

Holistic risk-based quality management starts with de-risking the protocol before your study goes live. Identification of potential issues that may arise is crucial to effective risk assessment before the study begins. We help you proactively drive quality by designing quality into the study protocol.   

  • RBQM SOPs & Gap Analysis

We help your organization implement a system to manage quality throughout all stages of the trial process. Besides providing you with the appropriate templates, we help identify gaps in the existing standard operating procedures and recommend changes based on industry best practices.

  • Centralized Monitoring

Centralized Monitoring within a risk-based framework can alleviate many of the considerable barriers compared to traditional site-based studies. Our team of experienced Central Monitors helps you oversee the conduct of your trial and timely address risks while the study is ongoing.

  • Quality of Clinical Data Report

Unbiased, customizable Quality of Clinical Data Report, meticulously crafted to complement the clinical due diligence process. By furnishing a reliable, unbiased, and comprehensive clinical data assessment, buyers can confidently make informed decisions in pharmaceutical M&A.

Consult with our MyRBQM FSP Team

Reach your risk management goals faster.

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