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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

Biopharma Group Celebrates Its 30th Anniversary

Established in 1989 as Biopharma Process Systems Ltd., the company initially focused on freeze drying equipment to the pharmaceutical & biotechnology industries and fast became a leading supplier of equipment in the UK & Ireland. In 1997, Biopharma Technology Ltd. was formed to offer a freeze drying R&D consultancy and lab services, with Dr. Kevin Ward joining the team in 2000 to expand the in-house expertise, services and training courses.
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White Papers

Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services

DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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Industry Events

Bio Europe Spring 2019

25-27 March 2019, Messe Wien Exhibition and Congress Center, Vienna

BIO-Europe Spring® is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe®, and continues the tradition of providing life science companies with high caliber partnering opportunities. Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative startups.
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