Day: March 7, 2024

Experimental data from research in non-human primates, which is almost always rhesus monkeys, is considered critical for establishing the safety and efficacy profile of many new drugs in market approval applications to the FDA. So, the ethical and legal acquisition of animals for this research is an important consideration. This week, an expose in Bloomberg … Read more

There are a few important considerations for the Informed Consent Document (ICD), also called the Informed Consent Form (ICF), used by sponsors to consent clinical trial participants which could improve the quality of the consent process and possibly increase trial participation. The design of the ICD varies extensively due to the experience of the sponsors … Read more