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.

SpecimINSIGHT? - formed through a strategic alliance between Covance and Global Specimen Solutions - puts all of your specimen data in one place, giving you the power to perform in-life study interventions and optimize trial design.

Planning for clinical trial testing can be challenging for a nimble biotech with limited resources, unique study requirements and the pressures of making the next program milestone on time.