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.
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.
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
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?
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.