November 5th 2024
Moving towards the development of mature quality management systems.
October 15th 2024
The need to boost education, shift culture, and embrace new technologies.
June 5th 2024
Under the new extension, FDA and CluePoints will enhance CluePoints’ SMART software to address a broader range of regulatory concerns.
April 4th 2024
A study conducted by the Tufts CSDD in collaboration with CluePoints and PwC revealed that slightly more than half of sponsors and contract research organizations have adopted risk-based quality management approaches.
March 11th 2024
Analysis assesses the relative percentage of quality issues detected via SDM that clinical study teams considered critical.
Impact of FDA Project FrontRunner on Oncology Drug Development
Webinar Date/Time: Tuesday, December 10th, 2024 at 11am EST | 8am PST | 4pm GMT | 5pm CET
Navigating the Future of AMR: Insights and Innovations in Clinical Development
Webinar Date/Time: Tuesday, November 12th, 2024 at 10am EST | 7am PST | 3pm GMT | 4pm CET
RBQM—Better, faster insights: The keys to success
Webinar Date/Time: Thursday, September 19th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST
From Local to Global: The Power of Centralized Hubs
Webinar Date/Time: Tuesday, September 10th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST
Implementing Digital Biomarkers in Clinical Trials: Early Success and Best Practices
Webinar Date/Time: Tue, Mar 26, 2024 11:00 AM EDT
Transforming Clinical Trial Oversight with Generative AI
Webinar Date/Time: Thursday, March 14th, 2024 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
The Past, Present and Future of Mobile Visits in Decentralized Clinical Trials
Webinar Date/Time: Wed, Mar 27, 2024 11:00 AM EDT
Using Machine Learning and NLP to Improve Central Monitoring Documentation
Study teams often face challenges in maintaining detailed and accurate documentation of risk signals.
Decentralized Clinical Trials: Being Audit Ready and Avoiding Pitfalls
Site and project management teams play major roles in risk-management and monitoring performance.
Reinventing Prospective Study Data Acquisition & Delivery
Webinar Date/Time: Tue, Oct 17, 2023 11:00 AM EDT
Ukraine War's Impact on Clinical Research: Evidence from Key Risk Indicators
Overall rate of significant KRI results for sites located in Ukraine has consistently risen since 2021.
ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?
Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.
Oversight Method Identifies Critical Errors Missed by Traditional Monitoring Approaches
Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.
Industry Trends: Cycle Time to Resolve Risk Signals
Metric derived from CluePoints central monitoring platform assesses average total cycle time from risk signal creation until closure.
How to Rescue ‘Failed’ Clinical Trials and Minimize Risks
Strategies for intervention—or, ideally, averting potential pitfalls from the onset.
Harnessing the Power of Scientific Surveillance
Statistical methods used via this technique in centralized monitoring.
Leveraging RBQM Technology to Enable Sponsor-Level Clinical Trial Oversight
Webinar Date/Time: Option 1: Thursday, May 11th, 2023 at 9am EDT | 6am PDT | 2pm BST | 3pm CEST Option 2: Thursday, May 11th, 2023 at 2pm EDT | 11am PDT | 7pm BST | 8pm CEST
The Role of KRIs in Process-Driven RBQM Success
As challenges like regulatory adherence, cost, and timelines become more complex, sponsors are seeking out new ways to incorporate risk-based approaches.
Quality Tolerance Limits: A Review of Industry Trends
Industry sees high increase in the use of QTLs.
Addressing Operational and Technical Challenges in Home-use Point-of-Care Device Development and Deployment
Webinar Date/Time: Mon, Feb 13, 2023 10:00 AM EST
Identifying Important Risk Indicators in Clinical Development
Study indentifies trends in most commonly used KRIs.
Moving Beyond the Checkbox Approach With Risk-Based Quality Management
With risk-based quality management (RBQM), the industry is uniquely positioned to amend Murphy’s Law and propose something new—“Everything that can go wrong, we can work to identify and prevent.”
Clinical Study Audits: The Quality Management Approach
Advancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.
Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 3)
Series Part 3—Methods for early detection of risk and summary.
Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 2)
Series Part 2—The process of defining QTLs.
Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 1)
Series Part 1—Introduction and the relationship between QTL and KRI.
Unlocking the Potential of Risk-Based Quality Monitoring
COVID-19 may have accelerated the adoption of RBQM, but it is the intrinsic benefits that are cementing its continued use.
Developing Critical Thinking Within Centralized Monitoring Teams
Developing a higher level of critical thinking can create a comprehensive risk story and properly direct mitigations throughout your organization.
De-Risking Trials with Science-Driven Oversight
Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.
Clinical Trial Evolution: The Drive to Update ICH E6
Researchers aren't taking full advantage of advances in trial technologies. A lack of clarity in the current version of the International Council for Harmonization "Guidelines for Good Clinical Practice", could be the problem.