August 2006

Cultivate Your Clinical Researchers, Pharma

Friday, August 25, 2006

Pharma companies know they have to reach out to new and inexperienced investigators to maintain capacity for growth in emerging regions. Investigator capacity is a major issue in these markets because they have experienced such significant growth in recent years. In the U.S., though, companies have taken more of a sink-or-swim approach when introducing physicians to clinical research, and they could be making a big mistake.

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The Name Game

Monday, August 21, 2006

It’s a call I made in January. So what took SFBC so long to decide to change its name to PharmaNet? While the move took a little longer than expected, it is another sign that new CEO Jeffrey McMullen and his PharmaNet-ters still have a solid chance to turnaround the troubled former SFBC.

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Prisoners As Study “Volunteers”

Thursday, August 17, 2006

A recent Institute of Medicine Report has recommended that drug testing be allowed on prisoners, thereby lifting a decades-old ban on this practice. The recommendation is drawing both criticism and support from government and industry.

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Is India Ready For Phase I Studies?

Tuesday, August 15, 2006

India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer – and others would agree – is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies…

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