Based upon US FDA Workshop Report April 16 2018 In response to the FDARA( Food and Drug Reauthorization Act) of 2017, the US FDA recently convened a workshop to evaluate inclusion & exclusion criteria in clinical trials. This workshop was attended by...
So you need to implement a training program at your organization…where do you even begin? Training/learning programs can exist in a number different forms. Sometimes they are a collection of courses, documents, and training classes that have been developed over a...
The pharmaceutical sector has been slow to adopt technologies designed to boost efficiencies in the very complex business of developing new therapies (Chart 1). Fortunately, this is changing as sponsors and contract research organizations embrace technologies that...
In a sweeping gesture to better protect human research subjects, sixteen US federal agencies issued a revised Common Rule on January 19, 2017, the first update since 1991. The final rule, officially known as Federal Policy for the Protection of Human Subjects, aims...
Released by the International Council on Harmonisation (ICH) in November 2016, Good Clinical Practice’s second revision, R2 has been making waves in the clinical research industry. In March 2018, the US FDA released E6(R2) Good Clinical Practice: Integrated Addendum...