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Reading Time: 2 minutes Join us next week in Frankfurt to hear from Bayer Head of Data Sciences & Analytics Benedikt Egersdoerfer and others to exchange best practices in transforming clinical development.

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Reading Time: 3 minutes Once a problem is detected, we must ensure that it is documented, along with its associated actions and resolutions.

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Reading Time: 4 minutes When it comes to risk assessment, it’s critical to look beyond what a CRA does.

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Reading Time: 3 minutes Risk assessment must go beyond the concerns of operations or monitoring teams and span the entire organization – because the conversation is no longer just about monitoring.

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Reading Time: 3 minutes The famous quote “Those who fail to learn from history are doomed to repeat it” seems appropriate when describing the pharmaceutical industry, at least according to our track record over the last few decades. It often feels like Groundhog Day, and we are Bill Murray hitting the alarm clock before realizing “Oh, here we go again!”

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Reading Time: 5 minutes On May 2nd, 2023, the US Food and Drug Administration (FDA) took a significant step to support the use of decentralized clinical trials (DCTs) by releasing a draft of guidance fully devoted to DCT practice. The FDA defines DCTs as “clinical trials where some or all of the trial-related activities occur at locations other than […]

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Reading Time: 4 minutes The Pancreatic Cancer Action Network has launched Precision Promise, which it calls, “the first large-scale precision medicine trial that will put the patient at the center of every decision.”

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Reading Time: 3 minutesClinical trials are complex, and their success depends heavily on organized, efficient documentation. Trial Master File management is critical in ensuring that documents are accessible and accurate. But TMF management can be overwhelming for sponsors and CROs. TMF expertise and resources in the industry can be sparse. To address this challenge, Granular Level, a leading […]

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Reading Time: 4 minutes Much like driving a car on new roads, you don’t necessarily know what is around the next bend, so you must constantly monitor your surroundings.

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Reading Time: 2 minutes Imagine that you are the director of clinical systems at a life science company. Your goal is to ensure that the clinical trial succeeds.

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Reading Time: 4 minutes You just decided to invest a significant portion of your innovation budget to power your clinical trial with new mobile health technology. Now what?

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Reading Time: 5 minutesAs the clinical trial data acquisition landscape expands, the industry requires new approaches to support the rapid pace and increasing diversity of data sources. Thus, it’s not surprising that the focus of clinical data management teams is shifting from reactive, exhaustive data cleaning to proactive, risk-based clinical data science. This fundamental shift requires clinical data […]

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