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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

Signant Health Appoints Lawrence Miller as Chief Technology Officer

LONDON & PHILADELPHIA – June 13, 2019: Signant Health, formerly CRF Bracket, has appointed Lawrence Miller as Chief Technology Officer. Signant unites electronic Clinical Outcomes Assessment (eCOA), eConsent, Patient Engagement, Interactive Response Technology (IRT), Clinical Supply Management and Endpoint Quality into the industry’s most comprehensive patient-centric suite of technology solutions and services. An accomplished innovator, Miller brings unique vision and expertise to a Signant team already committed to advancing clinical research with its next-generation technology portfolio.
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White Papers

pAVEway™ expression system for the efficient expression of therapeutic proteins

Fujifilm Diosynth Biotechnologies

One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells. The Escherichia coli pAVEway™ expression system described here has been developed to ensure high product titres and efficient scale up to GMP manufacture, whilst minimising many common issues seen in other expression systems, such as ‘leaky’ expression (expression of recombinant protein in the absence of inducer).
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Industry Events

SCOPE Europe – Summit for Clinical Ops Executives Europe

17-18 September 2019, Barcelona, Spain

Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical innovation leaders, clin ops execs, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the Rest of the World. The event will feature opening and closing plenary keynote sessions, five conference tracks, interactive breakout discussion groups, and networking. It is an opportunity for leaders from large, mid-sized, and small pharma, specialty pharma, biotech, vendor companies, and academic research centers to come together to share best practices and discuss the new era of analytics-driven and patient-centric trials.
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