Category Archives: News


CluePoints’ Founder to Present on Risk-Based Monitoring at FDA/AdvaMed Conference

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The 10th Annual FDA/ADVAMED Medical Devices and Diagnostics Statistical Issues Conference, taking place on April 26, 2017 to April 27, 2017, brings together leading authorities from FDA, industry, and academia to address statistical topics through two tracks – therapeutic device and diagnostics. Hear directly from FDA and industry experts to better understand the latest statistical trends and issues facing medtech organizations today.

CluePoints’ Founder, Marc Buyse, will talk at a session on using Risk-Based Monitoring as a way to both improve data quality and streamline clinical trial costs. Marc will describe an implementation of Central Statistical Monitoring using software that automatically performs a large number of statistical tests on all available data in multicentre clinical trials, resulting in a high-dimensional matrix of P-values which are summarized in an overall score for each centre, the score is analogous to an average P-value, with the low scores indicating the centres that are statistically most different from all others.

Washington Marriott at Metro Center, 775 12th St NW, Washington, DC 20005


 If you haven’t registered already, we recommend registering soon to avoid disappointment.

See you there!


ICH E6 Rev 2 – Ask the Experts

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Last week, we hosted our second webinar of 2017, Implementing Risk-Based Monitoring – What Does the ICH E6 Rev 2 Mean for My Company? There were many great questions from the attendees. In fact, we had so many questions that we couldn’t get through them all! So as promised, we’ve documented the most common questions, along with our answers. Enjoy!

QRisk-Based Monitoring sounds like the FDA encouraging Sponsors to begin looking at Data from Sites earlier on in the Study timelines. So why are the Sites beginning to feel their “hair is now on fire” for faxing and copying HIPPA sensitive data over email and fax. This message/ perception needs to be looked at.  And know that R2 is an FDA to SPONSOR revision and should affect sites on a day to day basis

A:  Indeed Risk-Based Monitoring methodology does encourage pro-active monitoring of relevant data and information from across all participating sites in a clinical trial – with emphasis being placed on centralized monitoring using intelligent/statistical methods that help to identify sites that are outside of an expected range across various quality (or performance) measures.  This allows teams to direct their attention more effectively to clinics that may need some support to overcome particular challenges (training needs, etc.).  However, the practice of asking sites to fax or scan various patient source documents for remote review is not called for by RBM guidance/methodology.  This practice is being employed by some sponsors (for good or ill), and unfortunately, sites are being told that this is a part of “RBM”.  In our view – and based on the FDA and ICH guidance already provided – this is NOT part of RBM.

Q:  How does ICH E6 R2 impact Computer System Validation, if any?

A:  There are indeed several paragraphs added to the new R2 update that address aspects of Systems Validation.  We suggest you review those additions directly in the current final version (publicly available).

QRemind us when patient profiles will be rolled out in CluePoints

A:  Patient Profiles are available with our April release – in two weeks!

Q: ICH E6 R2 indicates the need for monitoring reports for central monitoring.  We recognize central monitoring may be conducted by various roles (dedicated resources, plus physicians, scientists, quality, data managers, etc.) and is done on an ongoing manner.  Any insights on how to best document central monitoring activities in a ‘report’ without overburdening the organization?

A: What documentation is created is dependent on where and how the monitoring activities are occurring. The most important element is defining, up front, the process, audit trail (if there is one) and criteria for assessment/outcome determination and action/escalation.  There are 2 primary ways to capture central monitoring activities in a report format: 1. A simple event-driven report typically created by the user completing the assessment listing/describing data reviewed/outcomes/actions. Or 2.  An end of study or scheduled summary report of activities that lists the activities/outcomes undertaken in a specific timeframe or throughout the study (e.g. in an RBM platform, like CluePoints). The objective of capturing the evidence of your central monitoring activities is to demonstrate that you are adhering to your monitoring plan and addressing the risk appropriately.

Q: Will you please address with ICH E6 R2 takes effect in US and EU?  In other words, when are sponsors expected to make sure their studies comply with the new guideline. 

A: ICH E6 R2 is expected to be effective in Europe, per the EMA, as of 14 June, 2017, and the FDA has not set an effective date as of today.

QHow do one can detect fraud in RBM studies?

A:  There are a number of statistical tests that can be very helpful in detecting fraud in clinical research, and we recommend using a combination of these to be most effective.  A few to consider:

– Variability testing:  looking for unusual lack of variability in patient measurements for a single patient (e.g., across visits) or across patients within one site.

– Mean values:  identifying patients whose mean measurements are consistently in a different range than other patients within the study.

– Timing of Events:  As in the ePRO fraud case that we discussed, looking at an unusual distribution of patient event dates or times can be helpful as well.

Q:  Do you have any recommendation of document that we can study for identifying KRI?

A:  We suggest visiting the TransCelerate RBM website, which posts publicly available RBM guidance materials including a suggested library of KRIs to consider.  The Metrics Champion Consortium (MCC) has also developed a list of KRI definitions – with more detailed guidance on KRI algorithms and thresholds.  Access to the MCC materials requires membership first.  CluePoints also has deep expertise in KRI methods and best practices and offers consulting in this area (and RBM methodology in general) if you are interested.

QDo you know what type of data errors were typically caught by SDV? e.g. unreported AEs? 

A:  Indeed the analysis we performed revealed that SDV had a relatively bigger impact identification of unreported AE’s (7% to 12% of total AEs) than on finding data entry errors (1% of data).  Our conclusion was not that you should do 100% SDV of AE’s, but that relatively more SDV focus should be put on AE reporting than on other data.

Q:  Do you have any examples of effective rationale documentation for the chosen monitoring strategy

A:  An appropriate rationale will associate the identified and assessed risks related to the study’s critical data to the specific mechanism of review and evaluation specified in the plan. In other words, the monitoring strategy has to show that you have control and oversight in place for data points that impact safety and study outcome.

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CluePoints Launches Patient Profiles as Latest Addition to its Risk-Based Monitoring and Data Quality Oversight Solution

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13 March 2017

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has introduced Patient Profiles to its rapidly expanding platform. The powerful combination of Patient Profile reports, guided by CluePoints’ advanced central statistical monitoring, offers a new way for clinical teams to prioritize the investigation of atypical patients in clinical trials.

Patient Profiles provides detailed insight into patient experiences and offers a more targeted approach by identifying anomalies in data and ranking patients by their relative degree of atypicality.  The highly configurable Patient Profiles solution presents a rich set of customizable visualization options, including the ability to visually assess a chronological view of a patient’s visit, investigational product exposure, adverse events and concomitant medications – along with any additional relevant patient information. The solution will help to enhance overall quality management, guiding study teams to quickly and effectively characterize risk signals and enable centralized medical and safety reviews within the CluePoints platform.

“The addition of Patient Profiles to CluePoints’ portfolio aligns with our vision of expanding data exploration capabilities at both the patient and site level,” commented Steve Young, chief operations officer at CluePoints. “Reinforced by the voice of our customers, the solution will revolutionize the patient profiles review process by prioritizing and illuminating ‘at risk’ patients.

“Our agile product methodology is enabling us to rapidly evolve our solutions and exceed the expectations of our customers, delivering tangible value to them. This latest addition will significantly improve the efficiency of patient data review processes because customers can target their efforts on the patients and data that matter most.”

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.

Media contact

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


CluePoints COO, Steve Young, to Present on Statistical Probability Analysis at MCC’s Central Monitoring Workgroup

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The Central Monitoring Workgroup will feature speakers from several solution providers who will each present and discuss the types of analytic methods that are relevant for centralized monitoring and data quality oversight.  The first speaker will be Steve Young, COO at CluePoints (and the Metrics Champion Consortium’s Central Monitoring Workgroup leader), who will talk about Statistical Probability Analysis including the specific types of operational issues that it can uncover.

The goal with this series is to help the MCC community to better understand the types of analytics available and how each of them can help to drive effective centralized monitoring.

Webinar Date & Time

Wednesday, 15 March 2017, at 10:00am -11:00am EST


Patient Profiles unveiled as latest addition to CluePoints’ Risk-Based Monitoring and Data Quality Oversight solution

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We’re thrilled to announce that version 1.11.0 of CluePoints’ Central Monitoring platform, the enabling SaaS platform for Risk-Based Monitoring,  will be available to users in April!  Version 1.11.0 adds an abundance of new features (as requested by customers) and extensions to existing functionality.

There’s lots to cover, so let’s get started.

Patient Profiles

We have added Patient Profiles to the platform. Users can design and customize the patient profiles template using an intuitive and visual interface.

Patient profiles offer a new way to investigate atypical patients by looking at summary information from different datasets. Different data representations are available: tables, graphs, and Gantt chart.

Machine Learning(Beta Version)

We have trained a machine learning model to help users to benefit from decisions made in the past. A model has been distilled from 10 million scores in order to predict scores that should be associated with signal. In this first version, a machine learning model is used to assist the user in deciding which scores should be linked to a signal. In terms of user interface, a filter allows the user to only display the scores that need to be linked to a signal. The user can confirm which scores are signals and which scores are false positives.

Improved Key Risk Indicators

Based on the feedback we have received from our users, we have made some improvements in the Key Risk Indicators:

  • No minimum volume of data required: Previously KRIs were only displayed when enough observations to fit a statistical model were available. In the new version it is possible to assess sites using KRI absolute value thresholds even if it is not yet possible to fit a statistical model.
  • Improved user experience and navigation: We have added additional filters, and better organized the information on screen to facilitate the assessment and review of the KRIs.

That’s all for now!

If you would like a demonstration of the new features, please email

About CluePoints

CluePoints is the premier provider of Risk-Based Monitoring and Data Quality Oversight Software. Our products utilize 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, EMA, and the new ICH (E6) addendum, CluePoints is deployed to support traditional monitoring and data management and can be implemented as the ultimate engine to drive Risk-Based Monitoring. The value of CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing optimization of central and on-site monitoring and a significant reduction in overall regulatory submission risk.

Like this post? Follow @CluePoints on Twitter for blog post alerts, industry news, and more!

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6th Annual CROWN Congress: Sessions you Can’t Afford to Miss + 15% Discount Code

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It’s really no secret that the evolving regulatory landscape for clinical trials is a hot topic amongst the community. Just take a look at the agenda for the 6th Annual CROWN Congress, it’s jam-packed with sessions focused on the eagerly anticipated ICH E6 revisions, the new EU 536/2014 clinical trial regulations, risk management and centralized monitoring.  Of course, with the increased pressures coming from the regulatory bodies, sponsors are racing to implement recommendations to ensure that their clinical trials run in line with guidance.

With that in mind, we’ve put together a list of the #CROWNClinical ’17 sessions that you absolutely can’t afford to miss:

  • Risk-Based Monitoring and the Centralized Monitoring Model – Mapping out and Executing a Centralized Monitoring Approach to Optimize Operational Quality and Efficiency

    Speaker: Steve Young, Senior VP of US Operations, CluePoints
    Date & Time: Wednesday, March 8, 2017, at 3:30pm

  • Changing Regulations – Evaluating the Changing Global Regulatory Environment and the Impact on Clinical Risk Management

    Speaker: Doreen McGirl, North America Lead, Global Quality Business Operations, Otsuka
    Date & Time: Thursday, March 9, 2017, at 08:30am

  • Proactive Risk Management – Proactively Planning for Risk Realization and Managing Response

    Speaker: Stephen Potter, Director, Clinical Development Quality, Pfizer
    Date & Time: Thursday, March 9, 2017, at 09:15am

  • Clinical Operational Shifts – Examining how Evolving Regulations, Quality Expectations and Risk Assessments are Driving Changes in Clinical Operations

    Speaker: Federico A. Feldstein, J.D., Vice President, Global Head of Bio Research Quality and Compliance, The Janssen Pharmaceutical Companies of Johnson & Johnson
    Date & Time: Thursday, March 9, 2017, at 1:00pm

Not registered yet? – use discount code ‘C846CLUEPOINTS’ to save 15% on registration.

If you would like to schedule some time to discuss the upcoming regulatory revisions, Risk-Based Monitoring implementation, or anything else, please send an email to

See you there!


CluePoints’ Risk-Based Monitoring Solution Receives Clinical Informatics News Best Practices Award

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Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring solutions for clinical trials, today announced that it has won a Clinical Informatics News Best Practices Award for “creating the ultimate Risk-Based Monitoring and Data Quality Oversight Solution.” The Clinical Informatics News Best Practices awards recognize outstanding examples of applied strategic innovation-partnerships, deployments, and collaborations that manifestly improve the clinical trial process. CluePoints is delighted to receive another accolade recognising the considerable efforts of all staff members. We are committed to driving better quality into clinical trials and creating a company that is fun to work for and with.

Since conception, CluePoints has been known for breaking new ground as an enabling technology for Risk-Based Monitoring (RBM), CluePoints’ Central Statistical Monitoring (CSM) software utilizes statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. Deployed to support traditional monitoring and data management as well as improved “risk-based approaches,” CluePoints’ CSM software can be implemented as the ultimate engine to drive Risk-Based Monitoring. The value in the solution lies in its ability to identify anomalies in data earlier, offering the opportunity to eradicate issues as they are uncovered, increasing patient safety and reducing risks of data quality and integrity issues when submitting regulatory approval.

In addition, CluePoints recently announced that they signed an agreement with the US FDA to explore a data-driven approach to quality oversight in clinical trials. This Cooperative Research and Development Agreement (CRADA) explores a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness. Anticipated benefits to the FDA of the CRADA’s data driven approach include the detection of anomalous sites which may have escaped detection previously, rapid turnaround of results, the ability to determine the nature and extent of data anomalies, the ability to explore the interaction of various factors with data quality.

Like this Post? Follow @CluePoints on Twitter for all the latest news!

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The FDA is Knocking at your Door – Are you Ready for an FDA Site Inspection?

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Are you ready for an FDA site inspection?

You may have heard that CluePoints signed an agreement with the FDA. This Cooperative Research and Development Agreement(CRADA) explores a data-driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness. This shouldn’t come as a shock, since The FDA has been very vocal about their stance on Risk-Based Monitoring1

In 2015, The FDA issued 17,2322 warning letters, that’s a whopping 92% increase on letters sent out in 2014. The statistics reinforce the fact that investigators are interrogating sponsor’s data and protocols more thoroughly than ever before. Now, picture this, The FDA is knocking at your door – can you say that you’re 100% confident that your clinical trial data meets the recommended standard set out by the FDA? If not, it’s time to take preventative action.

CluePoints’ RADAR™ service enables sponsors to achieve a data-driven understanding of risks upon which to base high-impact site inspection readiness activities. Our Data Analysts will undertake a comprehensive statistical analysis of trial data using CluePoints’ software to provide sponsors a ranked list of the most anomalous sites, highlighting the areas of risk across site and patient data.

Download CluePoints’ RADAR™ data sheet to learn how we can help you identify clinical sites that may be selected for inspection.

1 FDA Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to  Monitoring

2 FDA Enforcement Statistics Summary Fiscal Year 2015

Like this post? Follow CluePoints on Twitter to stay up to date!

Risk-Based Monitoring Software

Webinar: Risk-Based Monitoring Implementation – What does ICH E6 Rev2 Mean for My Company?

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With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to ensure appropriate consideration of risk in study design and management.

For this webinar, CluePoints is again teaming up with Paragon Solutions, to highlight the key changes in the mandate and explain how best to address these elements for successful Risk-Based Monitoring Implementation.

Expect to Learn:

  • Understanding the key ICH E6 updates related to Risk-Based Monitoring/Data Quality Oversight and their purpose
  • Understanding how Central Statistical Monitoring(CSM) and Key Risk Indicators(KRIs) will work for you
  • Critical-to-success methods for Central Statistical Monitoring and KRIs
  • Change Management – Using E6 R2 to support your organization’s transition to RBM
  • The Monitoring plan – not just for monitoring intervals anymore


Tuesday, March 14th, 2017, 3:00pm GMT/ 11:00am EDT/ 08:00am PDT (Timing reflects  daylight savings time)

CluePoints – Finalists in The Clinical Informatics News 2017 Best Practices Awards at SCOPE, Jan 24th – 26th in Miami

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We’re thrilled to announce that CluePoints has been named as finalists for the Clinical Informatics News 2017 Best Practices Awards, for our award-winning Risk-Based Monitoring and Data Quality Oversight Solutions. The Clinical Informatics News Best Practices Awards recognize outstanding examples of applied strategic innovation – partnerships, deployments, and collaborations that manifestly improve the clinical trial process.

The winners will be announced at the SCOPE Summit for Clinical Ops Executives in Miami, Florida on January 25, 2017 – wish us luck!

The nomination for this award follows news that CluePoints signed a Cooperative Research and Development Agreement (CRADA) with the FDA. This Cooperative Research and Development Agreement (CRADA) explores a data driven approach to selecting sites which exhibit anomalies indicative of fraud, misconduct or sloppiness.

Also, be sure to stop by our booth (#509) at SCOPE to learn more about Risk-Based Monitoring, Data Quality Oversight and how our agreement with the FDA is driving how the regulator is interrogating submission data to select sites for inspection.

See you there!