Risk-Based Monitoring

Webinar Date/Time: Tuesday, December 10th, 2024 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Webinar Date/Time: Tuesday, November 12th, 2024 at 10am EST | 7am PST | 3pm GMT | 4pm CET

Webinar Date/Time: Thursday, September 19th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

Webinar Date/Time: Tuesday, September 10th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

Under the new extension, FDA and CluePoints will enhance CluePoints’ SMART software to address a broader range of regulatory concerns.

In part 1 of this video interview series with Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints, Getz touches on the findings from a recent study on RBQM adoption.

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.

Analysis assesses the relative percentage of quality issues detected via SDM that clinical study teams considered critical.

Webinar Date/Time: Tue, Mar 26, 2024 11:00 AM EDT

Webinar Date/Time: Thursday, March 14th, 2024 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET

Webinar Date/Time: Wed, Mar 27, 2024 11:00 AM EDT

Study teams often face challenges in maintaining detailed and accurate documentation of risk signals.

Site and project management teams play major roles in risk-management and monitoring performance.

Webinar Date/Time: Tue, Oct 17, 2023 11:00 AM EDT

Overall rate of significant KRI results for sites located in Ukraine has consistently risen since 2021.

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.

Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.

Metric derived from CluePoints central monitoring platform assesses average total cycle time from risk signal creation until closure.

Strategies for intervention—or, ideally, averting potential pitfalls from the onset.

Statistical methods used via this technique in centralized monitoring.

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

As challenges like regulatory adherence, cost, and timelines become more complex, sponsors are seeking out new ways to incorporate risk-based approaches.

Industry sees high increase in the use of QTLs.

Webinar Date/Time: Mon, Feb 13, 2023 10:00 AM EST

Study indentifies trends in most commonly used KRIs.

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.”

Advancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.

Series Part 3—Methods for early detection of risk and summary.

Series Part 2—The process of defining QTLs.

Series Part 1—Introduction and the relationship between QTL and KRI.