Transforming risks into returns

Risk is a fact of life in drug development—but not all risks are created equal. The sources of risk vary, and the impact of the risks on patient safety data quality and study integrity vary.

However, there is one constant: On the path to bring new products to market, it is critical to identify, prevent, and effectively manage the risks that could impact patient safety, data quality, and regulatory compliance.

Our holistic approach to risk-based monitoring (RBM) can help you transform these risks into returns.

  • An RBM approach designed and implemented by a cross-functional team of experts who understand your clinical trial challenges—and have a full view of the returns enabled by RBM
  • Strategically target resources for the greatest impact
  • Prevent, mitigate and manage risk and build quality into your study—right from the start
  • Simple at the point of use
  • Aligned with the latest regulatory expectations

Your payoff: more effective and efficient use of resources, higher quality data, and greater value from your study.

  • RBM: Transforming risks into returns
  • We support your drug development goals with a proactive, preventative and systematic approach.

  • Target your resources for greatest impact & highest value
  • Your resources are directed to high ROI areas such as prevention and primary data quality—as opposed to time consuming back-end data cleaning.

    You can benefit from the flexibility to scale up or down and adapt efforts as study and site risk profiles evolve.

    A focus on fit-for-purpose quality prioritizes risks and errors that may impact patient safety, data quality, regulatory compliance, and drug approval.

  • Proactive planning & primary quality reduces likelihood of delays
  • Our operationally consistent implementation of RBM designs out risk and proactively accounts for downstream impacts. This helps to reduce the likelihood of delays, rework, and threats to quality and investigator enthusiasm.

    Leverage Covance’s extensive experience and quantitative forecasting expertise to proactively identify and mitigate risks and optimize trial conduct.

    RBM includes optimized site selection through Xcellerate® Clinical Trial Optimization®, helping better predict which clinical sites are likely to deliver the right patients—so you can engage them from the start and avoid sites that are more likely to underperform.

  • Clearly document risk-driven decisions & state of control
  • Regulatory compliance by design: effort is matched to the most important risks, preventing errors that would impact patient safety and study results.

    Actions taken to address risk are clearly documented, as well as preventative plans.

    Robust operational design and implementation focused on real-life pressure points support state of control: comprehensive team training, process design and optimization, technological enablement, and communication plans combine to prevent variability and loss of control.

 
RBM solutions for your success:
What ‘working smarter’ looks like

Successful RBM begins before your study does. Quality cannot be monitored, audited, or inspected in. Quality starts with a high quality protocol—and we can help.

Successful RBM is nimble and adaptive. Risks are not static, and will change during study execution and from study to study. That’s why our RBM processes are built to adapt to change over time.

The Covance RBM approach is firmly rooted in our well-established operational platform based on predictive, proactive, and preventative clinical trial management, driven by decades of clinical trial conduct expertise and experience.

Mouseover the chart below for details.
Preventing and managing risk for the life of your study

We systematically work to design out, reduce, and manage risk throughout your study. Covance’s RBM approach is:

  • Prevention-focused, to move past “find-and-fix” and proactively address issues before they arise
  • Flexible, to adapt to changing needs and risk profiles
  • Iterative, to feed information back into the RBM feedback loop and drive continuous improvement
Mouseover the chart below for details.
Fit-for-purpose quality through the continuum:
Start with the end in mind

Quality cannot be monitored, audited, or inspected into your clinical trial. Our RBM approach builds in quality before your study starts, to prevent the waste of time and resources during the actual study conduct.

How do we bring Quality to life?

Mouseover the chart below for details.
A total transformation in clinical trials
Covance believes that RBM is much more than an additional step in study planning and implementation or a simple tweak in processes and responsibilities.

Mouseover the pie chart for details.

Quality

Quality truly is in focus—and not just as an assumption. With quality by design as a core RBM principle and fit-for-purpose quality as the target output, RBM makes the shift from risk-naïve to risk-aware approaches clear. This is driven by a focus on proactively assuring quality with both upfront and ongoing evaluations. Just as important is centralized monitoring for performance: Capturing the discrete signals that may not appear meaningful if seen individually, but may have a significant impact if understood in aggregate.

Data

We see RBM as a transformation of how data is used in clinical trials: not just to document the past, but truly as a force to drive and improve decisions directly impacting the future.

Risk

Risk is dynamic and variable. Historic clinical trial models and risk approaches were not. Covance’s RBM approach incorporates both adaptation and variation—yet is designed to be operationally robust and scalable.

With an experienced partner, RBM offers you an opportunity to more efficiently and effectively address risks and proactively optimize patient safety and data quality.

Covance RBM: Transforming risks into returns.

Simple at the point of use

Covance’s RBM approach is designed to be operationally robust, efficient, scalable—and user-friendly. Ensuring compliance and taking the right actions at the right time is simple with our intuitive, end-to-end RBM roadmap for clinical trial staff. This includes:

  • Training to ensure adherence to the protocol and monitoring plan
  • Easily understandable data visualization and interpretation
  • Clearly defined operational steps to take to reduce or mitigate risk
  • Firm directions for documenting actions and prevention plans consistent with regulatory expectations

Simply put, we make it easy for everyone involved in your study to understand what they need to do; when, why, and how to do it; and how to document their actions—start to finish.