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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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MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita

MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
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ConsulTech GmbH

ConsulTech GmbH

ConsulTech is a consulting company founded in 1992. Since then, we have been supporting biotech-nology, pharmaceutical and medical technology companies as well as research institutions with the entire process of setting-up and executing proposals for R&D projects. In projects funded by the European Commission, ConsulTech supports the coordinator by resuming administrative tasks allow-ing coordinators and partners to fully concentrate on the scientific and technical success of the pro-ject. We solve financial and administrative issues, organise meetings, take care of the timely delivery of milestones and reports and much more.
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The Universe of Pre-filled Syringes and Injection Devices

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PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
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