CASE STUDY
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Assignment period: 3 years
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Locations: 1 site
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Flying Research Professionals deployed: 7
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Hours worked: over 380
Summary
A successful collaboration has come to an end. We had the privilege of supporting an exciting project for Proinnovera GmbH at a clinic in Berlin. After almost three years and over 3,800 hours of work, it was finally completed.
With a team of seven Flying Research Professionals, we cared for 40 patients with cold urticaria, cholinergic urticaria, and symptomatic dermographism in an AMG phase 1 study. Urticaria is a condition in which those affected develop itching and swelling after contact with various triggers (such as cold, sweating, or mechanical stimuli). The project examined the pharmacokinetics and pharmacodynamics following administration of CDX-0159, a humanized monoclonal antibody from Celldex.
Study success despite limited resources
The key challenge was integrating our Flying Research Professionals into an existing study team that had no capacity for new projects and wanted us to take on the Study Nurse tasks. Without this support, the site would not have been able to participate in the study, and its patients would not have had access to it.
Flying Research Professional in a leading role
In some cases, our Flying Research resources are used as an interim solution, but here we were able to manage the project from the outset and provide complete administrative support in addition to patient care.
Our approach was to assign one of our Flying Research Professionals to a lead role, ensuring that Proinnovera and all involved vendors always had a dedicated contact person, without placing any burden on the site's permanent staff.
