Despite the widespread availability of highly effective vaccines, chronic hepatitis B infection remains a major global health issue, and there are >350 million people chronically infected with the virus.

Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives.

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).