Monthly Features

Personalized medicine impacting study conduct

Sunday, January 1, 2017

As the analysis of genetic data is fast becoming a significant part of clinical research programs, both to enroll study participants and understand how drugs work, investigative sites are increasingly asked to collect genetic samples and conduct genetic screenings for clinical trials.

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Big Data in clinical trials: Promise and pitfalls

Monday, August 15, 2016

Privacy versus medical progress. Proprietary ownership versus public information. Cost-effectiveness versus unnecessary burdens. Welcome to the swirl of opinions and emotions around Big Data and its potential—or not—in the clinical trials industry.

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Mixed experience with the Sunshine Act

Monday, August 1, 2016

Pharmaceutical companies have finished submitting the third batch of data detailing their financial relationships with physicians and teaching hospitals under the Open Payments program, also referred to as the Physician Payment Sunshine Act. Investigators now face the prospect of implementing sophisticated new processes and systems that can track and verify clinical research grant payment information.

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Three resonating patient-centric initiatives

Friday, July 1, 2016

Sponsor companies are piloting patient-centric initiatives at a furious pace. Although few initiatives designed to engage patients as clinical research partners have achieved widespread adoption, several are making substantial inroads. In this issue, CenterWatch profiles three major patient-centric initiatives that appear to be resonating across the clinical research enterprise.

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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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