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European Pharmaceutical Contractor

A Little More Action

It is already apparent that this year will be remembered as a pivotal one for risk-based monitoring (RBM). All of the necessary forces have come together – regulatory, industry and technology – to accelerate adoption of this modern approach.

On the regulatory front, the FDA and EMA have given the green light to move away from 100% source data verification (SDV) in favour of greater use of off-site and central monitoring methods. Both agencies acknowledge that clinical trial technologies for computing, data management and analytics have proven superior to manual monitoring methods in studies.

Monitoring the conventional way with an attempt to verify every single datapoint is a time-intensive process that can stretch resources too thinly. SDV can displace attention from where it is most needed and can, in fact, reduce quality – as well as prohibiting the ability to proactively improve performance. Conversely, focusing on high-risk target sites is more likely to ensure subject protection, compliance and overall quality.

Quality Management

Since it means a lot of different things to different people, it is important to clarify exactly what risk-based quality management is. According to an EMA reflection paper, the definition is: “To identify, assess, control, communicate and review the risk associated with [a] clinical trial during its lifecycle” (1).

Many are beginning to see RBM as the ‘intelligent monitoring’ practice all sponsors should be using to most effectively manage trials. It involves understanding the risks of the trial, planning appropriately to monitor and mitigate those risks, and adjusting trial management based on actual performance of sites.

In light of the growing evidence of success in employing less frequent on-site monitoring, progressive pharmaceutical companies have begun undertaking major initiatives to incorporate RBM methodologies into their clinical research programmes. At the same time, seasoned clinical trial professionals and software developers at the forefront have started to unveil powerful tools specialised for RBM strategy deployment.

With an array of inspiration for the pharma industry to adopt RBM – ranging from quality improvement to economic advantages in conducting clinical trials – now is an opportune time for leadership to solidify the solutions. So what is keeping organisations from progressing from talk to actual implementation? Candid conversations with pharma companies over the past few months have revealed some common themes. Based on these discussions, below are the top three key guidelines to implementing RBM.

No One Correct Method
If your organisation has been unable to move forward because of an exhaustive search to find the best monitoring method, take heed: there is no one ‘right’ method to determine how you should monitor and the extent to which you should do so. The monitoring procedure will be tailored to your organisation, the study protocol, and the product being tested. Selecting a method, or a combination of methods, involves thoughtful analysis to understand what is specific to the individual situation. Only then do you have sufficient information to make an evaluation as to how to move forward with an RBM strategy.

Identifying what is unique about a specific product being tested is all part of the Quality by Design (QbD) method widely discussed within the industry. QbD is, in fact, the foundation of RBM; it ensures that an appropriate methodology is applied to understand study risks, enabling you to take action to mitigate those risks through monitoring, and adapt plans accordingly.

The results of the QbD process will have great bearing during technology selection at a later stage. Because every organisation, programme and study has its own tailor-made RBM plan, it is imperative to ensure that any tool under consideration has the capability to accommodate these differences.

A Systems Approach
The second key to successful RBM programme implementation is a systems approach. This means that processes, tools and people must all be working toward the same goal. The seemingly difficult task of creating an efficient RBM programme can be simplified by breaking the process into workable steps as suggested below:
  • Assess risk at both protocol and site level
  • Determine key risk indicators
  • Define performance thresholds
  • Determine action and response plans
  • Define the communication plan
  • Ensure continuous review and re-assessment
  • Adjust the plan when necessary
There can be no shortcuts here; each one of these is a step on the critical path to RBM success.

Technology is Essential
Historically, analysts have manually examined thousands of datapoints in clinical trials – but with the vast and ever-increasing amount of data available, the human brain is unable to do it all. Trial, operational and laboratory data must be considered – all coming from different sources. It takes powerful technology to bring these together into something meaningful and actionable.

With far less reliance on manual tracking, having the right tools to implement RBM is essential. Intelligent monitoring enables companies to monitor the details that matter, when they matter.

Look for technology-enabling tools that allow you to monitor more efficiently, based on the actual performance of participating sites. To accomplish this, the technology will:
  • Integrate data from multiple systems
  • Include customised alert capabilities
  • Provide short-, mid- and long-term trending capabilities
  • Generate, manage and track actions
  • Capture both quantitative and qualitative data to give insight into site performance
  • Integrate qualitative data from monitors and study teams
  • Generate data-driven action items to prevent and/or correct performance issues
  • Provide mid-term performance indicators showing how sites compare, enabling action or escalation of action as needed
  • Trend long-term site performance showing what to monitor, and how much to monitor, whether performed on-site or remotely
Stalled in Indecision?

For anyone considering implementing RBM, but waiting for the perfect point to do so, now is the time to get started. New monitoring technology has the intelligence behind it which, with the support of an experienced team, will move your company forward. Even if you are unsure of the best way to implement RBM, help is available to walk you through the entire process from planning to implementation.


1. EMA, Reflection paper on risk based quality management in clinical trials, 18 November 2013. Visit: www.ema. library/scientific_guideline/2013/11/ wc500155491.pdf

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Courtney McBean is the Vice President of Clinical Innovation at BioClinica. Previously, she was the co-founder and Chief Executive Officer of Blueprint Clinical, which was acquired by BioClinica in June 2014. Courtney has over 15 years of experience as a clinical researcher and cross-functional business leader, and also has expertise in creating evidence strategies to support product approval, as well as global market success in the healthcare environment. She has designed numerous clinical trials, including: preclinical, feasibility, pivotal, investigational device exemption, 510(k) and post-approval studies. Courtney earned her Master of Science degree, with a focus on public health research, at Colorado State University.
Courtney McBean
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