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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´s Ukraine expansion

HOME · NEWS · ARENSIA´S UKRAINE EXPANSION

As result of an exceptional start and achievements of our current dedicated clinical research unit in Ukraine, we are extremely excited to inform you that ARENSIA is expanding by opening a 2nd clinical research unit located in the downtown area of Kiev.  This expansion will allow us to support the increased demand of early phase studies in Ukraine, and increase our catchment area to support an even broader range of patients.

Ukraine is enriched with ~45 million inhabitants with approximately 5 million located in the capital city Kiev.  The country has a centralized healthcare system with extremely well trained and experienced medical personal.  

This 2nd clinical research unit is a state-of-the-art set up with 16 intensive monitoring beds (24 hour surveillance), with additional separate rooms for staff, pharmacy, sample preparation lab, sample storage facilities, meeting rooms, including a dedicated space for monitors etc. The unit is located within the Harmony Health Clinic, with which ARENSIA has an exclusive partnership in the field of exploratory clinical research.  

Operations at the new ARENSIA unit are starting on 1st July 2019.

As with all other ARENSIA units, this unit is entirely dedicated to perform complex Phase Ib, IIa, Proof of Concept trials with novel compounds involving PATIENTS across multi-therapeutic areas covering and not limited to:

  • immuno-inflammatory,
  • cardiology
  • endocrine/metabolic
  • respiratory
  • neurology,
  • oncology,
  • gastroenterology,
  • dermatology,
  • infectious diseases and
  • others. 

Due to our unique model we are able to explore other therapeutics areas/indications as required.

The unit follows the same SOPs as the other ARENSIA Clinical Research Units. All of the staff are trained accordingly. This enables a very efficient, uncompromised consistent high quality approach to sustain the highest patient accruals across various patient populations.

Following type of exploratory projects  - INVOLVING PATIENTS -  are performed in this unit:

  • First-into-Patients SAD/MAD adaptive design with novel molecules: safety, efficacy, dose finding
  • Drug-drug-interaction
  • Bioequivalence
  • QTc

ARENSIA has the ability to conduct sophisticated protocols with intensive PK/PD sampling as well as with long confinement.

The ICU is in the same building as ARENSIA clinical pharmacology wards. Immediate emergency care is provided by the ICU teams 24 hrs per day, 7 days per week.

Patient safety is our number one priority and we ensure that all necessary systems are in place to achieve this.

The Ukrainian regulatory authorities are very supportive of early phase clinical research with overall observed approval times (parallel submission to HA and EC) of 60 working days.

03.06.2019