Informed Consent Consulting

Speid & Associates provides expert Informed consent consulting services. This is tied very closely to expert drug development consulting.

Many biotechnology companies do a very poor job in creating the product label, which in Europe is the SmPC. The creation of these documents requires a thorough understanding of the disease, the drug, and the patient’s perspective. The writing task requires an understanding that the reading ability of the general population is not very high. Just think about the writing ability of the typical person today. Writing the informed consent document must take into account that research subjects have a readability of about 6 years old. Think about that.

When writing the informed consent document, you do not have to be an author of the caliber of Thomas Hardy or Jane Austen, but you need to understand how to write for someone who has the ability to read Jack and Jill, and this is particularly difficult when we take into account extremely difficult scientific concepts.