Services Clinical Development Early Stage

Central and
Risk-based Monitoring

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Quality by Design (QbD) is a forward-thinking approach that anchors development in predefined objectives, fostering a deep understanding of products and processes while encouraging robust process control.

Originally conceived within the manufacturing sector, QbD has made its way into pharmaceutical development and is steadily gaining traction in clinical trials.

Accelsiors, as an innovative clinical research organization, has not only adopted but enhanced QbD through QualityDRIVE™. This unique approach leverages QbD principles to heighten efficiency, safeguard integrity, and fortify the reliability of trial results.

Fundamentally, Quality by Design rests on four pillars:

  • Incorporating quality into the process
  • Using a scientifically sound risk-based approach
  • Understanding the design space
  • Crafting an efficient control strategy

The embodiment of these principles is found within our QualityDRIVE™ approach, which hinges on the identification of Critical to Quality factors (CtQs). These factors represent vital attributes of a study, whose integrity is paramount to protecting study participants, ensuring reliable and interpretable study results, and making accurate decisions based on the study outcomes.

This is where Risk-Based Monitoring (RBM) comes into play. RBM is a complementary strategy employed during the trial execution, focusing resources on significant and likely risks to data quality and processes critical to human subject protection and trial integrity.

In essence, RBM acts as a dynamic component within the QbD framework. QbD lays the groundwork, pinpointing the critical quality aspects during the design phase. RBM then uses this information to guide the monitoring strategy throughout the study. Working together, these methods form a robust shield to ensure the quality and safety of clinical trials. Their use is endorsed and encouraged by regulatory authorities worldwide, reinforcing their importance in clinical research landscape.
We focus on factors that are critical to the quality of your clinical trial. We streamline all key study stakeholders’ attention to preventing errors of relevance that could meaningfully impact outcome and conclusions of a clinical trial.

Let’s come with us on a QualityDRIVE™ journey! With our QualityDRIVE™ program you can always be one step ahead of problems. You will always be aware of issues that matter.

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