Monthly Features

Welcoming procurement onto the team

Sunday, May 15, 2016

For decades, procurement professionals have been the Rodney Dangerfields of the pharmaceutical industry: they got no respect. Procurement held up projects, got bogged down in protracted budget and contract negotiations, and was a hassle.

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Sites smothered by technology solutions

Sunday, May 1, 2016

Technology solutions help sponsors and CROs make better drug development decisions, streamline processes and reduce clinical trial costs. But for a majority of investigative sites, these same technologies get in the way of efficient operations and add to their already heavy workload.

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The long wave goodbye to phantom PIs

Friday, April 15, 2016

Efforts to reduce the number of phantom investigators—principal investigators (PIs) who are not adequately supervising their staff and clinical trials—appear to be having a measurable impact. But problems associated with, and the issues that cause, phantom PIs and their causes linger.

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Facing protocol amendments head-on

Friday, April 1, 2016

The unplanned costs and delays associated with protocol amendments have prompted many sponsor companies to identify new approaches to simplify protocol designs and reduce the frequency of protocol amendments over the course of the past few years. Yet a new Tufts Center for the Study of Drug Development (CSDD) analysis found that the majority of protocols still require substantial amendments, which led to significantly longer clinical trial cycle times and higher costs.

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CROs juggle proprietary and commercial systems

Tuesday, March 15, 2016

Third-party vendors have come to dominate the clinical trial technology sector, which was led by CROs a decade ago. At the same time, many large CROs continue to invest in technology solutions to differentiate their services and offer greater efficiencies in clinical development processes.

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Slow to negative growth in select emerging markets

Tuesday, March 1, 2016

A few years ago, Latin America and India were considered among the most promising emerging markets for conducting industry-sponsored clinical trials. Dramatic increases were predicted for both regions, and investigative sites anticipated an influx of new work. Unfortunately, growth in these markets has fallen far short of expectations.

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Top issues facing ClinOps executives

Tuesday, December 1, 2015

Never before have operating conditions for clinical studies been more difficult. Clinical operations groups face growing pressure to get drugs to market faster while improving efficiencies and study quality. Development costs continue to rise. At the same time, the logistics of conducting a clinical trial have become more complex in the increasingly competitive and regulated environment.

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