The US Food and Drug Administration last week alerted an untold number of drug makers that marketing applications containing clinical trial data prepared by an Indian contract research organization would not be accepted due to concerns about the integrity of the data.
A notice was posted on the FDA web site one day after the agency sent a letter to Semler Research Center, which is based in Bangalore, India, saying that inspections found “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.” The FDA inspected Semler facilities last fall.
The move comes two weeks after the World Health Organization issued a “Notice of Concern” to Semler for the same reasons. Specifically, the WHO examined company computer servers and found a spreadsheet file containing detailed instructions for manipulating drug samples that were used in clinical trials for its clients. The WHO inspections conducted inspections early and late last year.
To quote a distinguished colleague at Waters in the Boston area when I posted the letter last week: [They must be saying] “If only… That pesky spreadsheet hadn’t been found,…”
My rejoinder – What a tangled web we weave when first we document how we deceive!
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