Action Items

Research champions—Not your grandmother’s referring physicians

Tuesday, August 1, 2017

The changing ecosystem of clinical research—empowered by advances ranging from CRISPR Cas9 technology and genomic analysis of biomarkers to mechanobiology and predictive data monitor—calls us to reconsider the role of referring physicians in patient enrollment. These and other technologies will shift resources from the traditional investigative site model focused on a large number of sites enrolling many patients to a more networked model of sub-investigators focused on screening patients for specific biomarkers. 

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Embrace payment technology to improve processes

Tuesday, August 1, 2017

In today’s technology-enabled world, consumers expect instant gratification, especially when it comes to payments. The clinical trial industry, which historically has been slow to embrace new technologies, must recognize that it needs to adopt new payment technologies to continue to attract patients for clinical trials. The benefits that payment automation solutions can deliver to trials, such as increased patient retention rates and enhanced patient engagement, as well as streamlined internal processes, have never been more important.

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Standard data, extraordinary innovations in clinical trials

Saturday, July 1, 2017

As clinical trials require more robust and user-friendly systems to monitor data and conduct effective risk-based monitoring, the use of industry data standards can greatly drive efficiencies and reduce variations in data format from one study to the next. The increasingly wide acceptance of Clinical Data Interchange Standards Consortium (CDISC) standards, and subsequent requirement of the CDISC Study Data Tabulation Model (SDTM) standards , has opened innovation opportunities within the industry.

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Pharmacovigilance in the Russian Federation

Thursday, June 15, 2017

In the Russian Federation, two codes of rules for pharmacovigilance are presently used. The local regulatory body responsible for pharmacovigilance is the Federal Service for Surveillance in Healthcare (RosZdravNadzor) and the Federal State Budgetary Institution named the Centre for Monitoring and Clinical Economic Expertise under the RosZdravNadzor.

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Patient differences recruiting rheumatoid arthritis globally

Thursday, June 1, 2017

Second of two parts

In the May 2017 issue of The CenterWatch Monthly, findings from INC Research’s study of clinical trial perceptions among rheumatoid arthritis (RA) patients were highlighted. The study collected insights from RA patients in the U.S., U.K., Poland, Japan and Mexico, which helped show how best to engage with patients around the world.

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Resolving the conflict between feasibility and relevance

Monday, May 15, 2017

Multi-disciplinary teams tasked with the design of phase III clinical trials face a series of challenges. These include: determining the number of subjects required for statistically meaningful results, the time to complete the trial, budget and regulatory hurdles and guideline implications of the trial design.

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A project management office as a strategic enabler

Saturday, April 15, 2017

A project management office (PMO) typically focuses on project activities, resources and budgets required to execute and deliver projects. Moving the focus from the traditional tactical PMO to a strategic enabler allows company leadership to plan for innovative project efforts.

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Balance patient-centricity with CRA-centricity

Saturday, April 1, 2017

Keeping a clinical trial on track is analogous to traversing a tightrope with the help of a balancing pole. On one side is “patient-centricity,” a philosophy that helps to ensure success by focusing on patient needs and safety. At the other end is the concept of “CRA-centricity,” which involves empowering CRAs to build close relationships with investigators, resolve complex issues and proactively guide a study to success.

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