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“The Cancer Lottery” in MIT Technology Review (January/February 2017) provides an excellent overview of precision medicine in treating cancer by following the journey of an artist living with cancer for over 30 years.
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A small biopharmaceutical company with big aspirations and unlimited potential was not getting the personalized attention that they expected and deserved from their large CRO. Instead, their needs often took a backseat to the needs of larger organizations, which, in some cases, led to frustrating delays.
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Without question digital health technologies are revolutionizing clinical development and execution. From electronic patient reported outcome (ePRO) systems to wearable devices, they can, when used properly, provide many benefits.
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Last year in our blog post titled “The New Clinical Data Manager,” we wrote about some key changes to the clinical data manager role that have taken place in recent years. What is fascinating to me is the pace at which the versatile position continues to evolve.
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All the activity of a clinical study culminates in the production of a clinical study report (CSR). More than a written summary of the results of a study, among its contents are the protocol followed during study conduct, lists of investigators, and the statistical output and methods. If printed, a CSR could number 1000 pages or more.