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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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PHASE I SPECIAL POPULATIONS

phase i special populations

ARENSIA offers exceptional fast recruitment rates for renal and hepatic impaired 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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ARENSIA IS EXPANDING ITS RESEARCH CAPABILITIES IN COVID-19

HOME · NEWS · ARENSIA IS EXPANDING ITS RESEARCH CAPABILITIES IN COVID-19

Together with our partner hospitals in Romania, Ukraine and Moldova, we are joining more innovative clinical research work in the fight against the virus!

Over the last 12 weeks, ARENSIA has initiated numerous research projects with innovative compounds involving COVID-19 positive patients - all stages of disease severity - in collaboration with the leading hospitals in Bucharest/Romania, Chisinau/Moldova and Kiev/Ukraine. The studies are performed within the specialized red-zone departments dedicated to the diagnosis and treatment of COVID-19 patients. We also dispose of the needed infrastructure to enrol mild, asymptomatic or recovering patients.

On each and every COVID-19 project we are leaders in patient enrolment, with a 5+ fold enrolment rate vs. any other site participating in the same trial. We are proud to enable access to the latest, most sophisticated therapies to our patients in this difficult fight against the new virus!
The reason for this success is our unique local research infrastructure and the close collaboration with hospitals which serve as National Reference Centers for COVID-19 of the respective countries. 

The healthcare systems in Romania, Moldova and Ukraine have been set-up by government directive in such a way that all COVID-19 patients are concentrated in a few hospitals (National References Centers) in order to minimize the spread of the virus. These COVID-19 dedicated hospitals are equipped state-of-the-art with the latest generation imaging and lab technologies, disposing of large departments and skilled 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 min. to max. 6 hrs.

The above constellation enables ARENSIA to perform clinical trials quickly and most efficiently by involving COVID-19 positive patients with all stages of disease severity. We also have the capabilities to perform vaccine trials in this field involving healthy volunteers!

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 locations for the given project.

In each of the above countries, the relaxation measures have been ongoing since June 1st - with opening individual shops, dentists, hotels - and have progressed since then - by opening malls, restaurants, fitness facilities, etc. Consequently, throughout the summer the number of daily confirmed cases have considerably increased in all 3 countries. With the recent school openings, early and mid-September, plus the arrival of the colder seasons when most activities will take place inside, the local epidemiologists expect a 2nd wave from the end of September onwards.

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

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

29.09.2020
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