Risk Based Analysis: COVID Vaccines

There you have it.  The risk of taking an experimental vaccine is HIGHER than the BENEFITS. Choose accordingly. Gene Based Vaccines have NEVER been used on humans before, so what we’re witnessing now are human experiments. – Sucharit Bhakdi Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use”Continue reading “Risk Based Analysis: COVID Vaccines”

A Risk-Based Approach To Monitoring

A risk is any uncertain event or condition that might affect your project. Not all risks are negative. No single approach to monitoring is appropriate or necessary for every clinical trial. FDA recommends that each sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of theContinue reading “A Risk-Based Approach To Monitoring”