by Gretchen Parker | Nov 22, 2023
When new participants are recruited by current participants to become part of a study sample, it is called “snowball sampling.” This is a non-probability sampling technique that can be a practical way to identify and recruit individuals with certain characteristics to...
by Gretchen Parker | Apr 16, 2020
With the pandemic of COVID-19 affecting the way of life across the globe, companies continue to accelerate the clinical development of a vaccine or a therapeutic. The number of Covid-19 clinical trials has been steadily growing because of the increases in incidence...
by Gretchen Parker | Dec 3, 2018
In the latest example of regulations not keeping up with technology, on November 25, 2018, Marilynn Marchione of the AP published a report regarding He Jiankui’s claim that he had helped create the world’s first gene-edited babies using CRISPR-Cas9 technology. He...
by Gretchen Parker | Aug 18, 2017
To date, manufacturers have had three choices when completing a clinical evaluation report (CER): 1) performing a clinical study, 2) performing a clinical literature review, or 3) a combination of performing a clinical study and literature review. However, with the...
by Gretchen Parker | Aug 25, 2015
The National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) facility based on recent FDA 483s that were issued by FDA in May 2015. The facility makes products for certain clinical research studies...
