Monthly Archives

November 2016

Secrets to Successful Risk-Based Monitoring Webinar Poll Results

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Thank you to all who registered and attended CluePoints’ recent webinar with Paragon Solutions: The Secrets of Successful Risk-Based Monitoring Revealed. We hope that you found the webinar informative. Below you will find the poll results and the documented Q&As. The on-demand recording can be viewed here. Enjoy!

The Poll Results

1: How aware is your company of the Risk-Based Monitoring approach to study management?

We are actively planning to implement an RBM strategy


We have announced our plans to move to RBM strategy


We have implemented RBM strategy


We have not assessed RBM approach yet


What is RBM?


2: How many clinical systems are used to manage studies and data today?









3: When you send out communications across your enterprise, what term do you use to describe this approach?

custom coined term


Adaptive Monitoring


Quality by Design (QBD)


Reduced SDV


Risk-Based Monitoring


4: How many KRIs have you defined as standard/core for your enterprise?

5 or less








We have not defined any standard/core KRIs


The Q&A

1: Any data related to studies inspected by USFDA which had Risk-Based Monitoring approach against the traditional monitoring approach?

While there is no public domain data available on the success or failure of submitting an RBM study to the FDA – there is good data on the challenges in the existing model:

  • About 50% of sites fail to reach the planned recruitment targets.*
  • The majority if not all milestones missed in the clinical trials—more than 95% of clinical trials do not end on time and on budget as planned in the first place.*
  • 90% of the studies meet their recruitment goals, but at the expense of mostly twice as much time as originally planned.* The costs attributable to these delays are gigantic.
  • Too many avoidable protocol amendments, with a first amendment implemented even before the very first patient has been enrolled—most of them due to the rush towards “First-Patient-In”.

In addition, an analysis published by TransCelerate in 2014 (Steve Young was a co-author) revealed that – on average – only 1% of site-entered eCRF data gets corrected by the traditional approach of 100% on-site Source Data Verification and Review.**

* Tufts Center for the Study of Drug Development Impact Report “New Research from Tufts Characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices”. 15 (1), January/February 2013.

** Therapeutic Innovation and Regulatory Science “Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials”. November, 2014

2: If you were to use a single term that incorporates QBD and RBM but not use those in particular what do you suggest?

We like the ICH term of Quality Risk Management (QRM) – it is a broader term that encompasses the larger paradigm shift that is needed for this transition.

3: What do you think on implementing RBM in ClinPharm studies? Have companies implemented it in CP studies? (i do not mean FIH studies)

We strongly believe that the QBD and RBM approach should apply to any and all clinical research, including ClinPharm studies.  In particular, the approach of identifying and mitigating risk through study design, study planning and execution is simply the appropriate way to approach clinical research.  However, some of the operational details will look different depending on the study type.  For example, some of the more intensive statistical monitoring methods may not apply to studies of very short duration or with very few sites.  Similarly, the level of on-site monitoring and SDV/SDR will likely vary by study.

CluePoints Partners with Metrics Champion Consortium to Define Metrics and Standards for Centralized Monitoring

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8 November 2016

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) and Risk-Based Monitoring(RBM) solutions for clinical trials, announces its partnership with the Metrics Champion Consortium (MCC), an association dedicated to the development of standardized performance metrics to improve clinical trials. Drawing on the company’s vast expertise in Risk-Based Monitoring, CluePoints will work with the consortium to help drive collaboration in the development of a standardized framework for Central Monitoring, including identification and definition of what is included, who should be involved, and how best to manage the process.

“We are excited to have the opportunity to lead such an important initiative for the Metrics Champion Consortium” comments Steve Young, Senior Vice President of US Operations at CluePoints. “The industry is finally beginning to move forward to large scale adoption of RBM, yet there remain many questions on the topic of Central Monitoring, and so we look forward to driving clear guidance and standards for this critical component of RBM success.”

The Metrics Champion Consortium has created the Central Monitoring work group to help facilitate the exchange of knowledge and expertise in standardization of clinical risk management. Known for organizing work groups with the intention of providing metrics for the clinical trials industry, MCC has engaged CluePoints to work with them to more clearly define what Central Monitoring is for the industry.

“We are delighted that CluePoints will lead our Central Monitoring work group” comments Linda Sullivan, Co-Founder and President of Metrics Champion Consortium. “Results from our recent Risk-based Approaches to Monitoring Industry Survey show an increasing number of organizations use/plan to use central monitoring approaches in the next 12 months as compared to two years ago. This new MCC work group will bring sponsors, CROs, central & core labs, consultants and IT system vendors together to explore what key risk indicators, performance metrics and data should be included in central monitoring, what analytic approaches should be used to gain valuable insights and how organizations should use the insights to ensure patient safety and improve data quality. CluePoints’ experience with centralized monitoring and risk-based monitoring make the company ideally placed to bring the community together to share insights and align thinking to established, shared global standards.”

For further information on CluePoints’ solutions, please visit

About CluePoints

CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

CluePoints Media contact
Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749

About the Metrics Champion Consortium

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

For more information about MCC publications, metric sets & tools, metric education programs and how you can participate in future surveys and MCC work groups, please visit

Linda B. Sullivan – President, Metrics Champion Consortium
+1.317.622.0266 ext 102