Category: Uncategorized
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Supporting Content Reuse from Study Protocols: DDF Solution Showcase
At the last Digital Data Flow Solution Showcase, Regina Preciado from Content Rules and I had a chance to share how CDISC’s Unified Study Definition Model (USDM data standard) supports content reuse from clinical trial protocols. While USDM was initially conceived to facilitate auto-configuration of clinical systems based on more structured protocol elements (like the…
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Thoughts on Breaking the Document Paradigm: WPF Interview
I was recently interviewed for World Pharmaceutical Frontiers on one of my favorite topics: digital clinical trials and breaking the document paradigm. The theme of digital transformation in clinical trials runs all the way through this issue and provides a great grounding to current thinking. Clinical trials are plagued by inefficiencies, largely due to reliance…
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Change Management for Digital Protocols
The end of the year is an interesting time for a webinar about Change Management and Digital Transformation in clinical trials and drug development. What better time than just before Christmas to reflect on past transformation projects, the ones that we are happening now, and about digital transformations that are yet to come? That’s exactly…
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Clinical Trial Matching Solutions: Understanding the Landscape
In February 2024, I published a review in Applied Clinical Trials Online to outline the different approaches to patient-clinical trial matching. This is a complex and much discussed area which can be confusing. The article explores the complexities of using technology to match patients with clinical trials based on their medical profiles and the trials’…
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Navigating Toward a Digital Clinical Trial Protocol
In last October’s Applied Clinical Trials Online magazine, I wrote an article to provide context about digital Protocols. The article explores the concept of digital clinical trial protocols, which aim to streamline the processes of designing, managing, and implementing clinical trials. Traditionally, clinical trial protocols have been documented in Word or PDF formats, following the…
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Freeing “data” from the Documents they live in
Since early 2019, I have paid close attention to TransCelerate’s “process harmonization” portfolio of initiatives: For most of that time, I have been a very active participant in one or more of these, and for the past while, I’ve been actively partnering and supporting team members and organizations who continue to do this important work.…
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The Clinical Trial (digital) revolution might be for real this time
I’ve worked in clinical operations for decades. For decades, the transformational changes we’ve been excited about have been either incremental or cosmetic. Early in my career, for example, we transitioned from paper case report forms (CRFs) to electronic data capture (EDC). Modern studies are capturing more and more data directly from other sources, like laboratories,…
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Project Governance – Creating a Value-Added Clinical Operations Metrics Program – Part 3
In Part 1, I confessed my love for metrics and also talked about the need to understand the Critical Success Factors and Key Performance Questions that each of your stakeholder groups has. In Part 2, I talked about some of the challenges of implementation. Here, I’ll talk about the need to understand metrics in context and the…
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Project Governance – Creating a Value-Added Clinical Operations Metrics Program – Part 2
In Part 1, I discussed the need to begin by understanding Critical Success Factors and Key Performance Questions when you’re setting up a metrics program. In this article, I’ll talk about iterative approaches to implementation. Once you have figured out what performance questions you’re trying to answer, you can then determine which measures different stakeholders will use…
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Project Governance – Creating a Value-Added Clinical Operations Metrics Program – Part 1
I love metrics. In particular, I love the idea of using metrics to monitor the progress and the “health” of a program, and even to proactively identify project issues before they become critical. An ideal metrics program will also help identify where to look – which studies in a program and what aspects of those…
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