Study Conduct

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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ERT granted patents on clinical trial participant compliance

Tuesday, July 17, 2012 02:42 PM

Philadelphia-based ERT, a global technology-driven provider of health outcomes services to sponsors and CROs, has received two additional patents from the U.S. Patent and Trademark Office (U.S. Patent No. 8,065,180 and U.S. Patent No. 8,145,519).  The patents are titled System for Clinical Trial Subject Compliance and were acquired by ERT as part of its recent acquisition of invivodata.

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23andMe acquires CureTogether

Thursday, July 12, 2012 11:22 AM

Personal genetics company 23andMe has completed its first acquisition with the purchase of CureTogether, launched in 2008 to help people who live in daily chronic pain.

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OncoSec establishes UCSF clinical site for phase II Merkel cell carcinoma trial

Wednesday, July 11, 2012 10:22 AM

OncoSec Medical, a biopharmaceutical company developing the advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, has established the University of California San Francisco (UCSF) as the second enrolling site for its phase II Merkel cell carcinoma study (OMS-I110).

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CRI Lifetree opens new early stage research facility

Tuesday, July 10, 2012 10:23 AM

CRI Lifetree, a specialized, multi-therapeutic early stage research company focused on pain, human abuse liability, psychiatry, neurology and diabetes, has opened a new state-of-the-art research facility in Marlton, N.J. The new site raises the company’s total bed count to 250 and adds capacity to conduct complex clinical trials.

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Medidata-sponsored study identifies up to $5B in potential trial cost savings

Wednesday, June 27, 2012 03:37 PM

The results of a new research study performed by the Center for the Study of Drug Development at Tufts University School of Medicine and sponsored by Medidata Solutions, a global provider of cloud-based clinical development solutions, found that clinical data gathered from 25% of the procedures administered to patients may be unnecessary—and, in the aggregate, are responsible for $3-5 billion in overall clinical trial costs annually.

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