Newsletter | November 29, 2023

Best of November: Top 5 Insights in Clinical Technology

Clinical Tech Leader


#1 RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)

Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor, discusses the findings of the groups’ joint global research study with CluePoints and Price Waterhouse Cooper (PwC), the implications of the upcoming ICH E6(R3) guidelines, and the future of risk-based clinical trial conduct.

#2 Bringing RTSM In From The Cold

RTSM is often a standalone system, which brings many benefits to study conduct. Watch James Stringer's presentation from the October 2023 Clinical Leader Solutions Expo: IRT Showcase to learn how site burden can be reduced by having more consolidated platforms, while bringing enhanced benefits to the trial as a whole.

#3 Establishing TMF Quality Goals For Greater Trial Efficiency

Does your clinical development group rely on its TMF as a resource for designing and conducting trials efficiently? Would maintaining timeliness in filing complete, ALCOA-compliant documents to the TMF be enough if efficiency were a goal of every clinical trial? Explore why it's important to create TMF quality goals to improve overall trial performance.

#4 Patient Recruitment From A Site Perspective: Technology Meeting Today’s Challenges

Effective participant recruitment is crucial to a successful clinical trial, but recruiting eligible participants in sufficient numbers has long been a challenge. Learn how when used strategically and in conjunction with traditional enrollment methods, technology can significantly enhance patient recruitment efforts.

#5 An Overview Of FDA Efforts To Encourage DHT Use In Drug & Biological Product Development

The FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development earlier this year, representing the agency's road map on the topic. This article takes a closer look at the framework as well as related FDA efforts this year.