Cetero Research, the clinical research organization that fell under a U.S. Food and Drug Administration probe for allegedly falsifying clinical trial records, has reached a “final resolution” with regulators about which studies can stand and which ones must be redone. The FDA had raised questions about data from Cetero’s Houston bioanalytical laboratory over a five-year […]
Cetero Research‘s unsecured creditors will have a little more time to prepare a bid to buy the bankrupt clinical research organization. The bankruptcy court has extended the bid deadline for the CRO by 11 days to May 11, Outsourcing Pharma, reported. Unsecured creditors of Cetero last week asked the court for an extension, claiming the […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Cetero Research‘s unsecured creditors are challenging the bidding process for the clinical research organization claiming that the bankruptcy sale process is rigged in favor of the banks who are already lending to the company. Outsourcing Pharma first reported on the court filing, in which the unsecured creditors say the bid procedures are “seriously flawed, and […]
Cetero Research‘s bankruptcy reorganization is under way, but a sale of the beleaguered clinical research organization had actually been in the works for months. As the CRO worked with the U.S. Food and Drug Administration to address concerns about clinical trial data that was allegedly falsified, the company simultaneously shopped itself to potential buyers. A […]
Cetero Research, the clinical research organization that fell under regulatory scrutiny for allegedly falsifying clinical trial data, has filed for bankruptcy protection. The U.S. Food and Drug Administration last July disclosed its inquiry into Cary, North Carolina CRO Cetero, which raised concerns over data and test results over a five-year period. The agency said that […]
Cetero Research, the North Carolina clinical research organization that fell under a U.S. Food and Drug Administration probe this year for allegedly falsifying data, has made two new hires that should help the CRO maintain regulatory compliance. Michael Fillios is now chief administrative officer for the Cary, North Carolina company. David Coggin has been named […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The five-plus years of Cetero Research clinical data called into question by the U.S. Food and Drug Administration is being shortened by nearly nine months. The FDA in July disclosed an inquiry into the Cary, North Carolina clinical research organization that alleged Cetero workers falsified clinical trial documents and test results from April 1, 2005 […]