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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

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ARENSIA offers exceptional fast recruitment rates for renal and hepatic impaired patients.

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

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ARENSIA Opening a new Clinical Research Unit for multi-therapeutic indications Kiev, Ukraine

HOME · NEWS · ARENSIA OPENING A NEW CLINICAL RESEARCH UNIT FOR MULTI-THERAPEUTIC INDICATIONS KIEV, UKRAINE

As consequence of the increasing demand for ARENSIA´s capabilities as a specialist for early clinical trials in patients, as of August 2017, ARENSIA expands its operations with a new clinical research unit in Kiev, Ukraine.

Ukraine (45 Mio. inhabitants) with its densely populated capital Kiev (5 Mio. inhabitants) offers tremendous opportunities for efficient and high quality performance of clinical trials. The country has a centralized healthcare system with well trained medical personnel and a long tradition in clinical research.

The ARENSIA unit is dedicated to perform Phase Ib, IIa, Proof of Concept trials, in the following disease areas:

  • Oncology
  • Haematology
  • Immunology / Inflamation
  • Allergology
  • Cardilogy
  • Metabolics / T2DM
  • Pulmonology
  • Gastro-Enterology
  • Neurology
  • Gynaecology
  • Ophtalmology
  • Dermatology
  • Infectious Diseases (HBV/HCV)

The unit is located within the “SPIZHENKO” Clinic, with which ARENSIA has an exclusive partnership in the field of exploratory clinical research.  

“SPIZHENKO” Clinic is a large, privately owned multi-therapeutic clinic located in the green zone of Kiev´s suburb, leading in the field of oncology and radiology, as well as surgery and endoscopy. It is equipped state-of-the art with on-site clinical lab facilities and latest imaging technologies (incl. MRI, CT). It is also teaching site for the Kiev State Medical University, which is the largest medical school in Ukraine.

The Clinical Research Unit is state-of-the art, located in a newly built wing of the clinic, with 8 beds for intensive care monitoring (24hrs surveillance) plus rooms for staff, pharmacy, sample preparation lab, sample storage facilities, meeting rooms, rooms for monitors, etc. ARENSIA has access to all areas of expertise in the “SPIZHENKO” Clinic.

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

  • First-into-Patients SAD/MAD adaptive design: safety, efficacy, dose finding
  • Drug-drug-interaction
  • Bioequivalence
  • QTc
  • Phase I PK in Hepatic Impairment (all stages) vs. matching healthy

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

ARENSIA medical team consist of physicians (PIs and sub-investigators), specialists across various therapeutic areas, with year long experience in treating patients as well as working in clinical research.

The unit follows the same SOPs as the other ARENSIA Clinical Research Units and all staff is trained accordingly.

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 supportive of early phase clinical research. The overall approval times (parallel submission to HA and EC) are 60 days.

The research partnership between ARENSIA and “SPIZHENKO” Clinic aims to enable our clients the most efficient performance of early clinical trials in a high quality set-up, and ensure fastest patient recruitment in various populations.

03.08.2017