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Sarah Fal: Who is involved in the clinical data management process?
Kumar Komuravelli: In general, it tends to be clinical data managers as well as programmers and designers. To some extent, clinical operations, clinical scientific leads, biostatisticians and IT professionals are involved when it comes to the data collection...

In October, five biosimilar versions of AbbVie’s blockbuster Humira were given the green light to launch in the EU. Humira sales constitute between 55 percent and 60 percent of AbbVie’s revenues outside the U.S., and the effects of this biosimilar launch...

Cardiac toxicity is one of the primary reasons pharmaceutical products were withdrawn from the market in the past. The International Conference on Harmonization (ICH) provided the guidelines for rigorous testing of a compound in development for its potential...

With the rise of cellular therapies and individualized medicine, cold chain study management has become a common issue in the clinical trial setting. Let’s take a look at some of the issues surrounding trial material at -70C and colder. Ultra-low and...