Study Conduct

Baby research results potentially unreliable

Wednesday, August 24, 2011 12:35 PM

Tests of medical treatments in babies vary markedly in quality, at least as judged by the reports that make it into scientific journals, researchers say, according to Reuters.

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Greenphire, Mytrus partner to enhance study efficiency

Wednesday, August 24, 2011 12:12 PM

Greenphire, based in suburban Philadelphia, and San Francisco startup Mytrus have developed web-based solutions to streamline the arduous tasks of recruiting, retaining, and efficiently administering clinical trials.  Greenphire’s ClinCard System, a web-based patient payment, management, and communication platform, compliments the functionality offered by Mytrus and its innovative methods for allowing patients to participate in clinical research studies directly from their own homes.

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DIA issues guide to improve computerized clinical trial data

Wednesday, August 17, 2011 10:36 AM

The rapid uptake and incorporation of computerized systems and electronic data management into clinical research needs to be backed up by sound validation processes to ensure data quality and integrity are not compromised, says the Drug Information Association (DIA), according to PharmaTimes.

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The FDA has issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.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