1. Pfizer Drops Half of Enrollment in Lyme Disease Trial Due to Sites’ GCP Infractions
https://www.centerwatch.com/articles/26465-pfizer-drops-half-of-enrollment-in-lyme-disease-trial-due-to-sites-gcp-infractions
Who protected these Human Subjects in the Valor trial?
Pfizer recently announced it would have to remove nearly 3500 patients from its Lyme disease vaccine trial due to violations of CGP guidelines. What if this had been your trial? Losing 20% of your study subjects can ruin a trial, a program, or a company.
That is why MANA RBM developed Study Health Check. It is the first completely independent and objective quality assessment of study health.
Delivered within weeks using a simple consulting agreement and our proprietary software and methods, Executives can have a comprehensive view of the most important aspects of your trial conduct: primary endpoint process, safety assessments, and investigational product administration.
Your report will assess the three areas:
- Primary endpoint,
- Safety
- Investigational Product
In addition, you will receive information showing the distribution of errors across sites and regions and whether your CRO has identified the critical errors.
Study Health Check is priced for every company to be able to afford this critical and regulatory-required oversight of your trial.