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On a morning at a rare disease trial site somewhere in the US, a site director is welcoming her third new hire in six months. As the new study coordinator begins her day, she is confronted with a large stack of clinical trial protocols for the site’s 14 active trials. After a few minutes of flipping through and scribbling notes, she is interrupted to help screen a patient who has shown up outside of his visit window for a trial the investigator is not familiar with. Is this study coordinator adequately supported to ensure proper protocol is followed for every procedure or that all data were captured accurately on each trial?

Unfortunately, these scenarios, and others far more frightening, are not uncommon. Given high turnover and competing priorities, a lack of a true site engagement strategy can have unintended consequences, such as protocol deviations, unclean trial data, and costly delays. Members of the clinical trials industry believe all technology providers, no matter which challenge they are solving, have a responsibility to ease site burden, not add to it.

This article will examine a company’s best practices, learnt from working with thousands of sites using clinical technology, to help ensure sites remain engaged throughout the trial paying great attention to protocol adherence and data management issues.

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Dani Darasz is Associate Director of Professional Services at DrugDev and has more than 10 years of experience in the healthcare and pharma industries. Having spent some of her career at a clinical site, Dani leverages her site experience while leading the design and execution of DrugDev technology.

Lesley Freese is Senior Manager of Operations at DrugDev and is a Subject Matter Expert in the site engagement and site activation space. She spent many years running clinical trials at the site level before joining DrugDev to lead project management teams implementing the company’s technology.
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PHARM Connect 2019

Life science and business are going to meet at PHARM Connect on the 12-13 of March 2019 in Budapest, Hungary to continue the tradition of providing high calibre, customised professional partnering opportunities for pharma and biotech professionals from Central & Eastern European and beyond and deliver the crucial information they need to excel in their work. The influential annual gathering brings together over 400 global and regional decision-makers, top scientists, industry executives and business development leaders for the ninth time to identify new business opportunities, technologies, state-of-the-art formulation development strategies and to foster exchange of ideas on the role of the sector.
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14th Annual Biomarkers Congress

21-22 February 2019, Manchester Central Convention Complex, UK

Oxford Global is proud to present for the 14th year our flagship Biomarkers Congress, taking place 21 – 22 February 2019 in Manchester, UK. An updated programme ensures you will benefit from talks on the latest strategies and technologies impacting growth in the biomarker industry.
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