Risk-Based Monitoring

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

An increase in protocol complexity is paving the way for machine learning models to optimize trial design.

Study uncovers insights on the impact on safety, patient enrollment/retention, and compliance.

The long-held practice is effective in pinpointing the emergence of known and unknown risks to clinical development, study shows.

Recent analysis showed 81% of clinical trial sites using RBQM statistical data monitoring experienced an improvement in quality.

A review of industry methods and adoption trends in those trial segments.

Moving towards the development of mature quality management systems.

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

The need to boost education, shift culture, and embrace new technologies.

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

In an interview with ACT editor Andy Studna at DIA 2024, Hughes, co-founder and chief commercial officer of CluePoints touches on collaboration with FDA and using artificial intelligence in clinical research.

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

In the fifth and final part of this video interview series, 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 look ahead to the future of risk-based quality management and what adoption will look like.

In part 4 of this video interview series, 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 touch on what risks companies leave themselves susceptible to without the adoption of risk-based approaches.

In part 3 of this video interview series, 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 discuss what could be holding stakeholders back from adopting risk-based quality management.

In part 2 of this video interview series, 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 highlight what stood out to them from the results of a recent study on RBQM adoption.

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.