Monthly Archives: October 2016

NEWS

CluePoints Introduces Data Quality Oversight Service for Site Inspection Readiness

By | Blog, News, Site Inspection Readiness | No Comments

31 October 2016

Cambridge, MACluePoints, a leading provider of Risk-Based Monitoring (RBM) and Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced a new Data Quality Oversight service, RADARTM, aimed at helping sponsors achieve a data-driven understanding of risks to an inspection-ready level. As regulators insist that sponsors adopt more comprehensive quality oversight methodologies, this new service looks to move away from antiquated processes to a more rigorous statistical approach to operational quality assurance including preparation for site inspections.

CluePoints’ RADAR™ service harnesses the advanced statistical interrogation of clinical and operational study data to identify investigative sites with a preponderance of anomalous, missing or inconsistent data that may require inspection readiness action. The company’s Data Analysts conduct a comprehensive assessment using the software to identify these higher-risk sites and data which may have escaped detection previously. This rigorous approach is anticipated to benefit sponsor submissions by identifying anomalous sites along with the nature and extent of potential data issues.

“The launch of our ground-breaking RADAR service marks another exciting development in data quality-driven risk analysis. This unsupervised, independent solution will help clinical research organizations to move away from existing time-consuming, approximate and costly procedures” comments Franҫois Torche, CEO, CluePoints. “It analyzes data trends over time to help comply with regulators’ standards, ensuring data quality and ultimately mitigating risks and improving the safety of patients.”

Inspiring confidence throughout the process, this service is an extremely cost-effective alternative to traditional site inspection readiness planning. It provides a report that ranks the most anomalous sites, identifies areas of risk across site and patient data and anticipates where regulators might also target their site inspections. Companies are adopting the RADAR service to use across Clinical Operations, and now in particular for Clinical Quality, Auditing, and Inspection Readiness.  Sponsors can access all these benefits through CluePoints’ outsourced service approach, and alternatively can obtain the CluePoints’ platform for internal, enterprise level adoption.

For further information on CluePoints’ solutions, please visit www.CluePoints.com.

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
Patrick.Hughes@CluePoints.com
+44 (0) 7703 532 749

 

FDA Signs Agreement with CluePoints to Explore a Data-Driven Approach to Quality Oversight in Clinical Trials

By | Blog, News, Uncategorized | No Comments

12 October 2016

Cambridge, MA –  FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.  Misconduct in clinical research, including, but not limited to the falsification or omission of data in reporting research results, places all subjects in that trial at possible safety risk.  Fraud jeopardizes the reliability of data submitted to FDA, and undermines the Agency’s mission to protect and promote public health. FDA and other regulators rely on whistleblowers and site inspections to detect signs of possible misconduct.

Due to the volume of product submissions, FDA can only inspect a small proportion of clinical trial sites.  The determination of which sites to inspect can involve recommendations by clinical and statistical reviewers, CDER’s risk based site selection tool and FDA inspectors’ judgment and experiences.

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.  Under this CRADA, FDA and CluePoints, Inc. will develop and test enhancements to CluePoints existing software to produce an ordered list of “anomalous sites”, i.e. sites whose data are highly inconsistent with data from other sites; explore “moderators of treatment effect”, i.e. factors such as center, region, or country that have a statistically significant impact on the magnitude of treatment effect; add statistical tests and models to those already in the existing software; refine the scoring system used to identify outlying centers; add an exploratory tool to identify moderators of treatment effect; test and implement the software in a high performance computing environment; and develop a user-friendly interface for use by medical reviewers and other interested parties at FDA.

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, and the ability to explore the interaction of various factors with data quality.  These benefits are expected to not only accrue to the site inspection process and improve data quality for all reviewers, but may also inform the efforts of clinical and statistical reviewers to conduct sensitivity analyses, subgroup analyses and site by treatment effect explorations.

For further information on CluePoints, please visit www.CluePoints.com

About CluePoints

CluePoints® is a 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
Patrick.Hughes@CluePoints.com
+44 (0) 7703 532 749

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CluePoints Teams up with Paragon Solutions to Share the Secrets of Successful Risk-Based Monitoring Implementation

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CluePoints and Paragon Presents: The Secrets of Successful Risk-Based Monitoring Implementation Revealed

We’re delighted to announce that are our next Risk-Based Monitoring implementation webinar is open for registration! Register now – this is THE Risk-Based Monitoring webinar that you need to attend.

About the Webinar

With regulatory bodies such as the FDA, EMA, and the ICH all strongly influencing sponsors to adopt a risk-based and centralized approach to site and data monitoring, sponsors are often left wondering how to implement this new paradigm most effectively.

For this webinar, Steve Young, Senior Vice President of US Operations, CluePoints,  is teaming up with Karen McCarthy Schau, Principal Consultant, Paragon Solutions, clinical and regulatory experts to the Life Sciences industry, to arm you with all the information you need to plan, document, implement, and evolve a bullet-proof Risk-Based Monitoring strategy.

In this session, we will be laying the foundation for implementing RBM.

Key Takeaways

  • How to structure your organization to support Risk-Based Monitoring
  • How to determine what solutions/capabilities you need to do RBM
  • How to introduce your team to the concept of QBD and risk assessments
  • How to define KRIs and data points to support monitoring

Date and Time

Tuesday November 8th, 2016, 10:00 AM EDT/ 3:00 PM GMT