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By Maria Bonner and Kalah Auchincloss, Greenleaf Health | 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. Digital health technologies (DHTs) may include wearable, implantable, or software applications, among other approaches. This article takes a closer look at the framework as well as related FDA efforts this year. |
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| RWD: More Than Just Another Acronym | Article | Citeline | Real-world evidence is gaining prominence in the industry. Uncover how real-world data can not only be used for any clinical trial, but study sponsors can also use RWD to inform all stages of a study. |
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| Enhancing Clinical Trials By Linking Them To RWD | Poster | Medidata AI | Clinical researchers can get a better view of the patient journey by connecting patient trial data and real-world data. Learn how a standard EDC system can promote success when obtaining IRB approval. |
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| Embracing Accessibility: The Future Of Clinical Trials | Article | By Bryan McDowell, Clario | Better understand why accessibility stands as a crucial pillar for the prosperity of the biopharmaceutical and clinical research sector, having evolved into an all-encompassing industry imperative. |
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| Key Takeaways From The Recent FDA DCT Draft Guidance | Article | By Pamela Tenaerts, Kevin Potgieter, and Mohammed Ali, Medable | Get an overview of draft perspectives and key points to reinforce decentralized clinical trial training, oversight, and risk assessment to guarantee a study's integrity, patient safety, and success. |
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| Modern Architecture's Impact On UX In Next-Gen IRT | Article | By Ryan Ridge, YPrime | Explore how interactive response technologies built around microservices models can provide faster initial builds, more rapid change management, and improved built-in test automation. |
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| Mitigating Study Risk With Performance Analytics | Article | By Jenna Rouse, Pro-ficiency | Performance metrics for supporting risk-based management can be great, however, this author tells readers why collecting and analyzing data after a study has begun may not be the best approach. |
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| Despite an abundance of “e”-technologies designed to streamline various elements of the clinical trial process, many sites still rely on paper-based systems. Join the next Clinical Leader Live (Dec. 18), where we’ll discuss some possible reasons for this conundrum and what technologies are helping and increasing in adoption. Registration is free thanks to the support of YPrime. |
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