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 […]
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, 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 […]
If you don’t know Dateline NBC‘s Chris Hansen by name or even by face, you know him by formula: hidden camera reporting that offers an inside look at people saying and doing things they would otherwise keep under wraps. Hansen’s technique is perhaps best known for the “To Catch a Predator” programs in which he […]
Among clinical research organizations, INC Research is not the biggest, but by at least one measure, it stands out as the best. INC received the best service quality scores in the annual CRO quality benchmarking study conducted by Industry Standard Research, a Cary, North Carolina firm that focuses on CRO research. While INC may claim […]
Count Icon (NASDAQ:ICLR) among the clinical research organizations continuing the industry M&A activity. The Ireland-based CRO has acquired PriceSpective, a CRO with a consulting focus and expertise in drug pricing. Icon didn’t disclose what it paid for the PriceSpective acquisition. But Outsourcing Pharma reports that William Blair analyst John Kreger among others say the deal […]
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.
Quintiles is partnering with a Russian investment fund to create new companies doing clinical trial work in the Russian Federation. No financial terms of the definitive agreement with Russian Venture Company Biofund were disclosed. But the partners said that Russia, the ninth-most populous country in the world, represents an opportunity for clinical trials. “With a […]
PPD routinely strikes strategic partnerships with pharmaceutical companies. But the clinical research organization has entered a different kind of partnership in Scotland with the goal of streamlining the clinical trials process and speeding the regulatory process for new therapies. Wilmington, North Carolina-based PPD has entered an alliance with the National Health Services’s Research Scotland (NRS), […]
North Carolina clinical research organization Clinipace Worldwide is flexing its muscles abroad with an executive hire that boosts the CRO’s European operations. Dr. Jurgen Frisch has been named chief medical officer for Clinipace’s European operations. He will be based in the company’s offices in Zurich, Switzerland. Clinipace, headquartered in Morrisville, North Carolina, has experienced considerable […]
The roles that documentation serves in clinical research are to communicate to other health care professionals and to demonstrate the competence with which we do our jobs, and for clinical research, that means being able to prove that subjects were protected throughout the entire clinical research process. As inferred in the terms "clinical research" there are documentation requirements pertinent to a subject’s "clinical" status and there are documentation requirements pertinent to the "research" itself, thus increasing the documentation efforts required exponentially. While many look at informed consent as the main way to document patient protection in clinical research, this is only the beginning of the story.
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Quintiles is expanding its reach in personalized medicine, forming a new company that will conduct biomarker research and development in cancer. The company, Oxford Cancer Biomarkers, is based on technology developed at the University of Oxford. CancerNav is a proprietary DNA and protein-based test technology platform that can quickly identify biomarkers that can be used […]
Clinical research organization inVentiv Health is strengthening its healthcare research and analytics offerings by acquiring two businesses from IMS Health under an agreement announced Tuesday. IMS is divesting the two business units as a condition of an acquisition of its own. IMS last January announced a deal to acquire SDI Health, a Pennsylvania healthcare analytics firm. […]
Clinical research organizations are on a rebound and the CRO industry is poised for 2012 growth led by the largest CROs exercising deals with large pharmaceutical companies, according to a new report by investment research firm Morningstar. As a group, the publicly traded CROs that Morningstar covers increased revenue 11.1 percent year over year. “We […]
Clinical research organization AAIPharma Services has hired its new CFO from the executive ranks of another pharmaceutical outsourcing services company. Eric Evans joins the CRO from Patheon (TSX:PTI), a contract drug manufacturer based in Research Triangle Park, North Carolina. Evans brings more than 25 years of experience to the position. He has been Patheon’s CFO […]
Quintiles is expanding its healthcare social media reach with the launch of a new digital business unit that will help the company recruit patients for clinical trials. The new Digital Patient unit builds on the clinical research organization’s existing services for clinical trial recruitment and brings together two of Quintiles’ patient-facing online sites: MediGuard.org […]