Study Conduct

Vince & Assoc. awarded $5M FDA contract to conduct clinical studies

Wednesday, September 26, 2012 10:21 AM

Vince & Associates Clinical Research, a clinical research services company based in Overland Park, Kan., has been awarded a contract with the FDA’s Center for Drug Evaluation and Research (CDER) to conduct bioequivalence studies of innovator and generic drugs such as anti-epileptic drugs.

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Quintiles designates Comprehensive with Prime Site status

Wednesday, September 26, 2012 09:58 AM

CRO Quintiles has designated Comprehensive Clinical Development, a Miramar, Fla.-based clinical research company, as a Quintiles Prime Site—a distinction that gives Comprehensive an enhanced role in global clinical research and testing of new and more effective medicines.

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Mytrus’ informed consent iPad app to be used in multi-year global clinical trial

Wednesday, September 12, 2012 12:11 PM

Mytrus, a San Francisco-based innovative clinical technology and services company, announced that its iPad application explaining informed consent prior to clinical trial patient enrollment has been selected for use in a global, multi-year study supported by the National Institute of Neurological Disorders and Stroke (NINDS).

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MonitorForHire.com releases new mobile app

Tuesday, September 11, 2012 11:23 AM

Conshohocken, Penn.-based MonitorForHire.com, a patented, web-enabled management tool for locating and contracting independent clinical research monitors, has released a free mobile application. The app, designed for clinical research monitors registered with MonitorForHire.com, is available via Apple's App Store and Android's Google Play Store.

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BMS discontinues development of BMS-986094 for hepatitis C

Friday, August 24, 2012 02:45 PM

Bristol-Myers Squibb has discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in phase II development for the treatment of hepatitis C. This decision was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients in a phase II study the company voluntarily suspended Aug. 1, 2012. The FDA subsequently placed the compound on clinical hold.

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PCORI seeks input on draft methodology report

Wednesday, July 25, 2012 11:08 AM

The Patient-Centered Outcomes Research Institute (PCORI), an independent nonprofit organization authorized by Congress, has opened a public comment period for its draft Methodology Report,which proposes standards for the conduct of patient-centered outcomes research (PCOR).

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Pfizer: endpoints not met in first phase III study of bapineuzumab for Alzheimer’s

Tuesday, July 24, 2012 02:54 PM

Pfizer has announced the co-primary clinical endpoints—change in cognitive and functional performance compared to placebo—were not met in the Janssen Alzheimer Immunotherapy R&D (Janssen AI)-led phase III trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer's disease who carry the ApoE4 (apolipoprotein E epsilon 4) genotype (Study 302). Pfizer and Janssen AI are partners in the Alzheimer's Immunotherapy Program (AIP).

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Patient Recruiters International launches Clinicalstudy.org

Friday, July 20, 2012 01:05 PM

Carlsbad, Calif.-based Patient Recruiters International (PRI), a provider of direct patient access solutions for patient recruitment and retention services, has launched Clinicalstudy.org to host clinical trial web sites and landing pages for the registration of interested research volunteers.

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Medpace opens new clinical pharmacology unit, expanding phase I-IIa capabilities

Thursday, July 19, 2012 01:44 PM

Cincinnati-based Medpace has opened the Medpace Clinical Pharmacology Unit (CPU) in Cincinnati. The new 60,000-square-foot facility is double the size of the previous unit, increasing Medpace’s ability to conduct multiple studies with a total of 96 beds for overnight stays. The facility houses a pharmacy, processing labs and a dedicated patient recruitment staff for recruitment and screening of study subjects. The new CPU joins the Medpace global headquarters and the Medpace CRO.

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Synexus expands presence in South Africa

Wednesday, July 18, 2012 01:21 PM

Synexus has further expanded its global presence with the opening of a new in-patient facility in Pretoria, South Africa. Synexus now has a total of four sites in South Africa, which provide access to millions of patients.

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