EMA reviewing the conduct of studies at Semler Research Centre
Posted on 03/05/2016
The European Medicines Agency has started a review of medicines for which studies have been conducted at Semler Research Centre Private Ltd, Bangalore, India. This follows an FDA inspection that identified several issues at Semler’s bioanalytical site, including the substitution and manipulation of subjects’ clinical samples. The World Health Organization (WHO) has also raised serious concerns regarding data integrity and manipulation of study samples, following its own inspections of Semler’s bioanalytical and clinical sites.
Read full information on the EMA website