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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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Video Tour of ARENSIA Research Clinic in Kiev

HOME · NEWS · VIDEO TOUR OF ARENSIA RESEARCH CLINIC IN KIEV

We are happy to share with you some more positive news from ARENSIA: 

Remaining fully operational through the COVID-19 outbreak, ARENSIA has responded to the increasing demand from our sponsors by further growing and developing our Clinics in Kiev (Ukraine).

EXPANSION IN UKRAINE:

The first ARENSIA Clinic in Ukraine started its operations in 2017 on 500 sqm and with 8 beds in a leading oncology hospital in the Western part of Kiev. 

Opening of our second proprietary Research Clinic in Kiev in July 2019 was met with great anticipation. Consequently, the new facility of 450 sqm and 8 beds in a private multi-therapeutic clinic in downtown Kiev has been in increasing demand from sponsors for our know-how and our resources. This prompted us to work hard behind the scenes to double the capacity in this location and accommodate even more Phase Ib / IIa Proof of Concept patient trials across nearly all therapeutic areas!

As of April 1st the expansion has been completed, making ARENSIA the largest player in early clinical research in Ukraine with the largest and most modern Research Clinics dedicated exclusively to early phase trials in patients!

The new ARENSIA’s Research Clinic is located in downtown Kiev and disposes on over 1,000 sqm floor space. Click to watch a 1 min. video tour:  https://www.arensia-em.com/news-28-video-tour-of-arensia-research-clinic-in-kiev

  • 25 beds (for in- and out-patient protocols)
  • Separated area for infectious disease trials with own screening room, patients ward, sampling room and IMP storage 
  • 5 in-patient wards, with bed-side or communal TV, private WC & shower facilities
  • 5 dedicated consultation and screening rooms
  • Patient social/entertainment room
  • Patient communal kitchen
  • Fully equipped access/temperature controlled pharmacy with 2 laminar cabinets, one for oncology IMP
  • 2 separate biological sampling and laboratory processing rooms
  • 2 separate rooms for CRA/Monitoring visits
  • State of the art meeting/conference room equipped for 30 participants, as well as for online meetings
  • Advanced medical equipment from ECGs to infrared touchless thermometers
  • Enhanced access and security systems
  • Secure Fast WiFi across the clinic

ARENSIA is experiencing high support from the regulatory bodies in Ukraine, which  are keen to enable Ukrainian patients access to novel therapies as early as possible in the development programs, with approval timelines in range of 60 days. 

With a population of 45 Mio, Ukraine offers large pools of patients eager to contribute to clinical trials. A strongly centralized healthcare infrastructure helps leverage the large number of patients. This combined with highly skilled motivated physicians, Ukraine´s 30+ years in clinical research, and top quality data delivery (as proven by the numerous FDA inspections) qualify Ukraine as a very attractive environment for clinical trials.

COVID-19 UPDATE:

From the very beginning of the pandemic in early March, ARENSIA Clinics have implemented a comprehensive Business Continuity Plan (BCP) across all facilities in Ukraine, Romania, Moldova and Georgia. The BCP successfully ensured the safety of patients and staff, while simultaneously keeping study supplies and logistics chains on-going. During this time, ARENSIA’s Clinics have been maintaining 100% patient retention, as well as continued enrolment of new patients and initiating new projects, allowing our Sponsors to progress their research programs in the safest and most efficient manner. 

Starting from June 1st, the countries where ARENSIA Clinics operate - Moldova, Ukraine, Romania and Georgia - have lifted the state of emergency and have started gradually relaxing the lockdown measures. Travel within each of these countries is no longer restricted. Travel from/to other European countries is planned to resume in the upcoming weeks as well. 
Independent of the relaxation measures, ARENSIA stays committed to its BCP with the same strict sanitation and protective measures for patients, staff and facilities. Patient and staff safety is of paramount priority at all ARENSIA clinics. 

The continuation of all our activities was only possible due to ARENSIA’s unique set-up as independent Research Clinics at all locations, with own full-time employees, not dependent on external staff to deliver the clinical work, while being located in leading medical institutions in the given countries, which have been kept open due to their strategic role in ensuring uninterrupted patient care.

In such extraordinary circumstances, as we all have experienced over the last few months, it is essential to have full control over resources as well as full compliance, trust, and support from all team members. 

We stay at your disposal for any questions or inquiries/feasibilities.
With kind regards and stay safe!

17.06.2020
VIDEO INTRO

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