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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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News and Press Releases

CBIs Global Risk Based Monitoring Event

CBI’s Global Risk Based Monitoring Event is approaching, taking place in London on 13 – 14 September 2018, designed for benchmarking with international peers to gauge RBM performance, efficiencies, implementation and technologies.
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White Papers

Nasal Drug Delivery with a Focus on Chronic Rhino-Sinusitis

Aptar Pharma

Aptar Pharma have hosted a scientific roundtable on “Nasal drug delivery with a focus on chronic rhino‑sinusitis”. This international scientific forum was held in Paris, France on November 13th 2012. The roundtable was organized to explore and exchange views on the science of various forms of sinusitis and its related unmet medical needs.
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Industry Events

Outsourcing Clinical Trials Nordics 2018

30-31 October 2018, Copenhagen, Denmark

Following on from the success of the 2017 Outsourcing in Clinical Trials Nordics conference, Arena International is pleased to announce that the event will return for its 6th year in 2018. The 2018 event welcomes biopharmaceutical and medical device companies from across the Nordic region to share knowledge and challenges of outsourcing and clinical operations.
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