CRO Files Chapter 11 After FDA Alert on Faulty Clinical Trials

CRO Files Chapter 11 After FDA Alert on Faulty Clinical Trials

March 27th, 2012 // 12:15 pm @

Source: Pharmalot

Eight months after the FDA alerted drugmakers to reevaluate clinical tests conducted by Cetero Research due to falsified data and manipulated samples, the contract research organization has filed for bankruptcy. Why? The FDA notice put a strain on its finances because lenders viewed this as a breach of “applicable health laws and regulations” that amounted to a default on its loans, according to documents filed in US Bankruptcy Court today.

In light of the findings, the FDA had asked drugmakers to check their databases for trials that were used to support New Drug Applications and Abbreviated New Drug Applications between April 2005 and June 2010, and to be prepared to repeat or confirm the results. However, the agency later amended the timeframe to run through February 2008 after Cetero was able to demonstrate that electronic recordkeeping was adequate for the other time periods, according to the court documents.

The agency, you may recall, issued its alert after conducting an inspection and an audit, finding that Cetero failed to conduct an adequate internal investigation to determine the extent and impact of the violations, and failed to take sufficient measures to assure data integrity (back story with FDA statement here).

Cetero subsequently maintained that an internal investigation was conducted of its Houston bioanalytical laboratory in 2009 after discovering six chemists had misreported the date that samples were extracted prior to analysis. They did this to seek overtime pay for hours when they did not actually work. But the CRO insists reports were filed with the FDA and agency feedback was sought, although none was received. Cetero clients were also contacted, the CRO argued

As an aside, several former and current Cetero employees had once worked for MDS Pharma Services, another CRO that is now owned by INC Research and had rather similar problems with the validity and accuracy of test results. MDS Pharma early and late-stage operations were subsequently sold to INC Research and Ricera Biosciences, respectively

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