ASN 2017 -- Retrospective, real-world data study conducted using end-stage renal disease EMR data from Fresenius Kidney Care centers in the United States.

Oncology trials are undeniably complex. Discover how you can successfully mitigate risks and maximize trial success by creating a comprehensive strategy that plans for the differences in immunotherapy development and proactively monitors execution.

Running biosimilar studies in the U.K. has been a challenge for many pharmaceutical companies who have often struggled to attract clinicians interested in supporting their biosimilar studies.

Conducting a study of an orphan drug to treat pediatric patients with Niemann-Pick disease

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Cellular and gene therapies are now on the cusp of realizing the early promise of treating, and perhaps curing diseases that previously had little or no available therapeutic options.

PhUSE/CSS 2018 -- Ensuring that ADaM datasets conform to CDISC standards and FDA expectations is often done through expert review after content is complete. That retrospective approach may result in a quality final product, if there is enough time to do the same work twice (once incorrectly and once correctly).

PhUSE-CSS 2018 -- On many studies, the development of SDTM specifications can be optimized using SAS macros. During the creation of the SDTM data, the author manually identifies mapping rules and a certain level of metadata, for which CDISC review software or sponsor created specs can be used.

PhUSE-CSS 2018 -- Evaluating whether mapped data conforms to the applicable CDISC (SEND, SDTM or ADaM) standard is best done multiple times over the course of a study.

In the last decade, inflammatory disease drug development has shifted from addressing organ-related symptoms to a more holistic method that involves understanding the pathology and mechanisms behind this group of related diseases.