Risk-Based Monitoring

Comparator drug sourcing in the EU is shaped by a defined set of availability, regulatory, competitive, and logistical pressures, alongside practical strategies to reduce risk and protect trial timelines.

As clinical trials become more complex and decentralized, the role of the CRA is evolving from site monitor to strategic, digitally fluent partner, requiring expertise in hybrid oversight, risk-based monitoring, and multi-system data management.

How a unified approach to clinical data management, powered by artificial intelligence and advanced analytics, can elevate clinical trial monitoring and redefine how teams assess, act on and learn from data.

To maximize the impact of signal detection, KRI frameworks should follow a few guiding principles.

By adopting structured practices today, clinical trials can deliver diagnostics that are reliable, impactful, and ready for tomorrow’s healthcare needs.

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical strategies to manage risk, reduce delays, and support patients.

Clinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research teams to closely scrutinize federal fund certifications and document good-faith compliance efforts, even when policies stem from nonbinding executive orders.

Exploring stat-based testing for variables that identify deliberate data manipulation in clinical trials.

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

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.