CRO Cetero seeks bankruptcy protection

Monday, March 26, 2012 09:50 AM

Cetero, a CRO based in Cary, N.C., has filed for bankruptcy just eight months after the FDA caught the company manipulating samples and faking documents, according to Reuters.

The misconduct discovery, made last July, originated from two FDA inspections of Cetero’s Houston facility in 2010, followed by an internal investigation and an audit from a third party. Cetero, as an early-phase research and bioanalysis company, may have given drugmakers faulty documents that were then used as supporting evidence in applications to the FDA for drug approval, according to Reuters. Due to the discovery, the FDA warned drugmakers that studies supported by Cetero between April 2005 and June 2010 might have to be repeated or confirmed. However, the FDA has not made any allegations of fraud.

In the Cetero bankruptcy filing, filed in Delaware on March 26, the company claimed the FDA warning letter caused its “liquidity position to become severely constrained,” and some lenders stipulated the misconduct discovery was an event of default due to “apparent violation of applicable health laws and regulations,” according to Reuters. Cetero is using the Chapter 11 process to maximize recovery for these lenders, having reached a deal to sell the majority of the company’s assets in a credit bid. To aid in this process, Cetero has gained $15 million in debtor-in-possession financing to provide working capital.

Cetero’s listed estimated assets range from $1 million to $10 million. The company has a $11 million 2012 revenue to date and roughly $248 million in liabilities, according to the court filing.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs