Risk-Based Monitoring

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

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

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.

COVID-19 may have accelerated the adoption of RBQM, but it is the intrinsic benefits that are cementing its continued use.

Developing a higher level of critical thinking can create a comprehensive risk story and properly direct mitigations throughout your organization.

Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.

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.

Exploring effective strategies for sponsors and CROs to ensure both their CRAs and sites are supported for high levels of site acceptance and streamlined remote monitoring.

Organizations implementing RBM continue to struggle with a number of questions regarding the relative contributions to quality of on-site monitoring, centralized statistical monitoring, and clinical data management reviews—and what role each activity should play.

CEO of MANA UBM, Penelope K. Manasco, explores the different approaches to determine what the right 'easy button' is to push to achieve effective clinical trial conduct and oversight.

The biopharmaceutical industry must establish customized approaches to managing Quality Management Systems within their clinical trials processes.

Centralized monitoring is the core of RBM and helps study teams decide on on-site monitoring activities and site intervention. Thus, the right mix of KRIs and Central Statistical Monitoring Reports is crucial for trial success.

The pharma industry needs an improved risk-based management approach to better handle the increased complexity of trials, to improve the quality of studies and to better adhere to new guidelines from regulatory agencies.