Theorem Clinical Research

Cetero

PRACS Institute closes; Chapter 7 imminent

Friday, March 22, 2013 01:23 PM

By Suz Redfearn
At 4:30 p.m. central time on Wednesday, March 20, the approximately 480 employees at PRACS Institute’s Fargo, N.D., facility—one of the largest phase I units in the world with 544 beds—were told via conference call that PRACS was shutting its doors, effective immediately.

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Cetero sold to investor group, renamed PRACS Institute

Wednesday, June 20, 2012 02:38 PM

Cary, N.C.-based Cetero Research has finalized the sale of the company to its investor group, led by Freeport Financial, following the company’s Chapter 11 bankruptcy filing court approval of the sale.

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Cetero reaches final resolution with FDA

Tuesday, April 24, 2012 03:10 PM

Cary, N.C.-based CRO Cetero Research has reached a final resolution with the FDA over studies the company conducted in its Houston bioanalytical laboratory between April 1, 2005 and June 15, 2010. Following months of open collaboration between Cetero and the agency, the FDA summarized its final decision:

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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.

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Cetero Research expands senior management team

Tuesday, December 27, 2011 11:49 AM

Cetero Research has reported two new appointments to its senior management team. Michael C. Fillios was named chief administrative officer, with leadership responsibility and oversight of human resources, information technology, project management, marketing and client services. David Coggin was named vice president, biometrics. He will oversee the operational management of PK/PD, data management, miostatistics and medical writing services.

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Icon and Bristol-Myers Squibb build on strategic partnership, extending it to early-phase work

Monday, September 5, 2011 08:00 AM

Icon and Bristol-Myers Squibb (BMS) have inked a preferred-provider agreement for early-phase development. This constitutes the CRO’s second sizable agreement with BMS; in June 2010, the two formed a strategic partnership, with Icon focused on providing global support for the drug developer’s clinical development pipeline.

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Cetero says FDA’s actions ‘difficult to understand’—company notified agency of chemists’ misconduct

Monday, August 1, 2011 08:02 AM

Large, early-phase CRO Cetero Research seemed blindsided by the FDA’s letter to the company last week accusing it of falsifying data and manipulating samples over a five-year period at its Houston bioanalytics lab.

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FDA inspections find Cetero faked records, manipulated samples

Wednesday, July 27, 2011 01:43 PM

Drug companies that had medicines tested by contractor Cetero Research might have to re-evaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples, according to Reuters.

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CRO Cetero appoints James Dixon as SVP

Tuesday, April 26, 2011 02:07 PM

North Carolina-based CRO Cetero Research has appointed James "Jay" Dixon to senior vice president, quality and compliance. Dixon has spent more than 25 years in the pharmaceutical, biotechnology and CRO industries.  

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FDA: Generic transdermal patches should be tested in divergent climates

Monday, November 22, 2010 09:06 AM

A patch that delivers medicine transdermally may act very differently on a resident of Fargo, N.D., than on someone in South Florida. Thus, the amount of medicine that enters their bloodstreams may be different. That’s the assertion of the FDA’s Office of Generic Drugs, and that’s why the regulatory body now asks that drug developers working on transdermal patches—at least in the generics realm—test their patches in multiple divergent climates.

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