COVID
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Proof of concept trials

PROOF OF CONCEPT TRIALS

proof of concept trials

ARENSIA delivers high degree of scientific and logistical expertise for Phase I/Ib/IIa and PROOF OF CONCEPT patient studies.

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COVID-19 RESEARCH

COVID-19 RESEARCH

ARENSIA has contributed to numerous research projects with innovative compounds enrolling more than 1,500 COVID-19 patients.

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REGULATORY PROCESS

regulatory process

ARENSIA has the know-how to successfully manage the regulatory process in various Eastern European countries.

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COVID-19 CLINICAL RESEARCH

Since July 2020, ARENSIA has contributed to numerous research projects with innovative compounds enrolling more than 1,500 COVID-19 patients - all stages of disease, as well as healthy contacts and recovering patients (post COVID, long COVID) - in collaboration with leading hospitals of Bucharest/Romania, Chisinau/Moldova and Kiev/Ukraine. The studies are performed in red-zones of specialized departments dedicated to the diagnosis and treatment of COVID-19 patients.

The healthcare systems of Romania, Moldova and Ukraine have been set-up by their respective governments so that COVID-19 patients are  concentrated in a few hospitals (National Reference Centers) in order to minimize the spread of the virus. These COVID-19 dedicated hospitals feature state-of-the-art equipment including latest generation imaging and lab technologies; they dispose of large departments and highly skilled and experienced medical teams to support all necessary treatment protocols (incl. oxygen supply / ventilation / intubation etc.); RT-PCR tests are done on-site with turnaround times of 45 minutes to a maximum of 6 hours.

This context enables ARENSIA to perform clinical trials quickly and most efficiently by recruiting COVID-19 positive patients with all stages of disease severity. We also dispose of the necessary infrastructure to enrol mild, asymptomatic as well as recovering patients (long COVID, post-COVID syndrome).

Consequently, in all COVID-19 clinical research projects conducted, we have been leaders in patient enrolment, with more than 20-fold enrolment rate vs. any other site participating in the same trial.The key of this achievement is our unique local research infrastructure with operational teams dedicated to COVID-19 (full-time ARENSIA medics, nurses, project coordinators, pharmacists etc) who are working closely with hospitals serving as National Reference Centers for COVID-19 in their respective countries. 

We are committed to providing our patients with access to the latest, most sophisticated therapies in this difficult fight against the new virus!

As new COVID-19 variants are appearing, we stay ready to continue to contribute to new COVID-19 projects and to help patients access innovative medicines early on in the drug development process, as well as to support Sponsors’ projects by reducing recruitment periods for their programs, thus enabling them to progress faster to the next phases of research.

Depending on the type and number of COVID-19 positive patients required by protocol (asymptomatic, mild, moderate, severe) - the targeted timelines, study design requirements, and following careful assessment of all our resources / competitive trials – we suggest one, two, or all three ARENSIA countries for the given project.

The regulatory approval timelines in Romania, Moldova and Ukraine are 7-14 days! The regulatory bodies in these 3 countries are fully committed to ensure PRIORITY REVIEW for COVID-19 clinical research submissions. ARENSIA has the expertise to perform regulatory submission in all countries, with outstanding support from local authorities.

We are happy to support extension of existing projects as much as we love joining new projects in the fight against COVID-19! Do not hesitate to contact us for questions or feasibilities!

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