Monthly Archives

February 2017

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.

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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!

Six Ways to Get the Most out of Outsourcing in Clinical Trials West Coast ‘17

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There’s only a couple of weeks to go until Arena’s flagship event, Outsourcing in Clinical Trials West Coast returns to Burlingame. The must-attend event brings together over 700 clinical professionals from the Bay Area and beyond, to discuss clinical outsourcing strategies and overcome key challenges within clinical operations. From sessions to booth activities to after-hours events, there will be lots to do while you’re in San Francisco. Whether you’re a first-timer or a seasoned attendee, here are 6 things you can do to make sure you get the most out of this year’s conference:

Find out who's going

Following #OCTWestCoast on Twitter is an excellent way to find out who will be at this year’s event. Tweeting your plans to attend and getting involved in conversations ahead of time is a great way to make your presence known as well. You may also want to follow @CluePoints for live updates during the event.

Plan ahead

Arena International provides the full conference schedule in advance, so it’s easy for you to build your personal session schedule before you head out to Burlingame. Take advantage of the agenda to decide on sessions that you would like to attend.


Preparation is key. Think of the questions you would like to have answered and don’t hesitate to ask them during the Q&A’s for the sessions you attend. If you don’t feel like asking your questions in front of an audience, you can have a chat with the speaker afterward.


Attending outsourcing in Clinical Trials West Coast isn’t only about attending sessions, it’s also about networking. More than 700 people from the clinical operations community are expected to attend the event, which leaves lots of opportunity for learning from peers. We highly recommend attending after parties to get advice, exchange ideas, and make those all-important connections with members of the clinical operations ecosystem.

Strike while the iron is hot

Don’t wait to follow up until the conference is over. Use the momentum of the event and send follow-up emails and Linkedin requests while the conference is still fresh in people’s minds. Take notes on the business cards you collect so you don’t forget the most important points of discussion. Even better – use business card apps such as CamCard to store all of the information digitally.

Share what you learn

Make sure that you share your key takeaways and learnings. Set up informal meetings with your colleagues and managers to share your newly acquired insights. Use social media – whether it’s Twitter, Linkedin and/or Facebook to share what you learned at the show for a more immediate impact.

Join us at the event

If you’re going to be in Burlingame, be sure to stop by booth #31 to meet our Risk-Based Monitoring and Data Quality Oversight subject matter experts!

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.

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