Semler gets WHO notice of concern over violation of ideal la
The World Health Organization has alleged "fraud" and pointed to violations of good laboratory and clinical practices at Semler Research, a Bengaluru-based contract researcher that was pulled up last week by USFDA on data integrity issues. "Manipulation of at least five studies over an extended period of time indicates this is a common practice," the world health body wrote in its 'notice of concern' report on April 12 on the clinical research outfit. WHO said upon investigations of study documentations for products like atazanavir, acetazolamide, celecoxib and saquinavir, inspectors identified evidence of such manipulations by comparing concentration time curves for specific pairs of study subjects. "It is of the impression that to execute this type of manipulation, several staff members on various levels within the organization have to be collaborating and coordinating. The issue is thus not confined to a single person operating outside ..

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