Study Conduct

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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Finding investigators and patients for faster trials

Friday, April 15, 2016

In the January issue of The CenterWatch Monthly, I wrote about using insurance claims and electronic health records (EHR) to understand patient availability for clinical trials. Combined, these sources can tell you if enough patients meet the criteria, enabling redesign and better planning.

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Veteran Affairs, Seven Bridges partner on Million Veteran Program

Monday, April 11, 2016

Seven Bridges, a biomedical data analysis company, has signed a Collaborative Research and Development Agreement (CRADA) with the U.S. Department of Veteran Affairs (VA) to support two key research initiatives for the VA’s Million Veteran Program (MVP). The MVP is a national, voluntary research program funded by the VA’s Office of R&D, with the goal of partnering with Veterans receiving their care from the VA Healthcare System to study how genes affect health. Seven Bridges will serve as an industrial collaborator on the MVP, supporting the development of a hybrid cloud for large-scale data analysis, and a genotype-phenotype graph analysis engine.

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INC Research, CISCRP collaborate on patient awareness

Wednesday, April 6, 2016

INC Research Holdings, a global phase I to IV CRO, has announced a strategic collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process. Through this collaboration, INC and CISCRP will jointly develop and implement educational initiatives designed to bring greater awareness to the importance of clinical trial participation in advancing public health.

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Three Questions: Tom O’Leary, Icon

Monday, April 4, 2016

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn connected with Tom O’Leary, chief information officer of Icon.

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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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Trial volunteer death throws spotlight on disclosure

Friday, April 1, 2016

On Jan. 1, 2016, clinical researchers heard news that they dread: Healthy volunteers in a drug trial experienced serious side effects. One volunteer in the French trial died and five others were hospitalized with neurological symptoms. Questions now remain as to how this happened and how the tragedy will affect clinical trials in Europe and in the United States.

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Refocusing on risk mitigation in starting clinical trials

Friday, April 1, 2016

While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential risks waiting to derail a company’s multimillion dollar development programs. These risks include patient enrollment issues, site staffing shortages, drug supply logistical problems, and regulatory delays. Risk-based challenges are escalating as clinical trials become more global and complex, and as market pressures keep rising for new therapies at an ever-increasing pace.

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goBalto launches study startup solution Select

Thursday, March 31, 2016

goBalto, a provider of cloud-based clinical study startup solutions, has released goBalto Select for optimizing site selection. With this release, goBalto becomes the first life science software vendor to offer a complete end-to-end platform for starting clinical trials, from site feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget.

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The ongoing CRA shortage: Competency versus experience

Monday, March 28, 2016

Ongoing concerns about a global shortage of clinical research associates (CRAs) were rekindled last week at the Clinical Trial Collaborations conference in Boston, Massachusetts, prompting debate about the reasons for and solutions to the problem—and particularly about a two-year experience requirement described by many as arbitrary.

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