Study Conduct

GNS constructs immuno-inflammation model with BMS trial data

Wednesday, August 17, 2011 10:17 AM

A computer model that can support virtual clinical trials in the field of immuno-inflammation is the goal of a new collaboration between Bristol-Myers Squibb (BMS) and US-based healthcare analytics company GNS Healthcare, according to PharmaTimes.

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FDA issues guidance to improve clinical study quality

Monday, August 15, 2011 01:40 PM

The FDA has issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.

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CTTI report recommends risk-based monitoring

Monday, August 15, 2011 08:02 AM

Almost 90% of those conducting clinical trials within the commercial drug industry always perform on-site visits to their study sites. In contrast, about a third of academic, government or cooperative groups involved in research do. And yet, neither monitoring method is based on any evidence that it improves the quality of the data, as no such evidence yet exists.

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Sequenom partners with LifeCodexx in first European commercial partnership

Thursday, August 11, 2011 10:03 AM

Sequenom, a life sciences company providing innovative genetic analysis solutions, has partnered with LifeCodexx, a company focused on the development of clinically validated Next Generation Molecular Diagnostics, for the commercialization of prenatal laboratory testing services in Europe. The companies have agreed to collaborate in the development and launch of a trisomy 21 laboratory developed test and other aneuploidies testing in Germany, Austria, Switzerland, and Liechtenstein, with the potential for additional launches in other countries. 

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Pharma industry: Still not budgeting accurately

Monday, August 8, 2011 08:00 AM

Survey shows 57% still relying on Excel spreadsheets

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Survey: training needed for India’s growing clinical trial industry

Friday, August 5, 2011 10:44 AM

India needs to tackle regulatory delays and introduce “comprehensive and ongoing” training of clinical investigators if it is maximize the country’s potential as a destination for international clinical trials, the results of a recent survey suggest, according to PharmaTimes.

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Essex scolded by FDA after phony clinical trial sponsor

Thursday, August 4, 2011 12:08 PM

Earlier this year, the FDA has issued an alert that some fictitious applications were submitted to several Institutional Review Boards. The agency noted that the name and address of the clinical investigator listed on a required FDA form are the same as that used in a sting operation conducted by the US Government Accountability Office two years ago, according to Pharmalot.

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NWBT expands clinical sites in ongoing brain cancer trial

Thursday, August 4, 2011 11:36 AM

Northwest Biotherapeutics has expanded its number of clinical trial sites, and now has 12 sites across the U.S. open and active, where patients can enroll in the ongoing clinical trial of DCVax immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. The company also reported that a substantial number of additional sites are in progress. With the 12 sites already open and active, and others in progress, the company is on track to fulfill its prior projection that it will have 15 sites open and active in Q3 of this year.

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Comprehensive Clinical Development expands operations

Wednesday, August 3, 2011 11:35 AM

Comprehensive Clinical Development, a clinical services company delivering high-quality clinical trials from phase I-IV with three pharmacology units and five patient-focused centers,  has expanded  the company with the relocation of its corporate headquarters in Miramar, Florida.

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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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