Semler Research Centre which has been issued a data integrity notice from the USFDA has said that it is in the process of reviewing the concerns raised by the agency.

The global regulatory major has indicted the Bengaluru-based clinical research organisation for having submitted false data for the  drug approval process. In this regard, USFDA released a notification on April 21, 2016 stating it observed  serious violations of regulations, including the substitution and manipulation of study subject samples during an inspection at the company’s bio-analytical facility in Bengaluru held between September  29, 2015 and October 9, 2015.

The regulator stated that there are data integrity concerns in case of drugs, which were earlier approved based on the clinical research done by Semler and their applications are not acceptable.

“The sponsors or the companies are now asked to repeat the clinical research of drugs as their New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) have been rejected,” noted USFDA.

Commenting on the USFDA notification, Semler spokesperson said, “We understand the seriousness of this notification. We are in the process of reviewing the concerns raised by the agency. We have engaged high quality consulting firm to review the data and we would be providing a detailed response to these concerns with appropriate steps undertaken as advised by the Agency. SRC stands committed to uphold the GCP (good clinical practice) standards of studies conducted at its facilities. “

“The agency has also notified that they have not identified any serious safety concerns with the products for the studies conducted at SRC,” said the Semler spokesperson.