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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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Defining “Controlled Environment” at ARENSIA´s Early Phase Research Clinics

HOME · NEWS · DEFINING “CONTROLLED ENVIRONMENT” AT ARENSIA´S EARLY PHASE RESEARCH CLINICS

In a world where every variable matters we introduce the concept of Controlled Environment. In research, where even one bit of information could potentially change the outcome, we know exactly how to keep all flows of information, coming IN or OUT, under control. What does it mean to really have Controlled Environment in clinical trials? 

1. Medical health systems that evolved from centralized medical care in Eastern Europe managed to keep a unique feature of access to information: medical history and previous treatments confirmations are not only available, but reliable.

2. As clinics in their own right, ARENSIA Research Clinics are fully integrated in the network of medical information flow of the countries, in which ARENSIA operates.

3. Research alliances with physicians allow our Research Clinics to deeply integrate into the medical community, resulting not only in efficient data collection when conducting the trial, but also in efficient follow-on measures to ensure patients safety in collaboration between ARENSIA investigators and physicians.

4. Research alliances with our patients allow us to control data quality coming from patient reports. Low placebo response rates confirm this fact for research conducted in ARENSIA Research Clinics. 

5. Systems implemented in our Research Clinics allow us to follow standardized clinical pharmacology procedures in all ARENSIA countries. ARENSIA proprietary research clinics are forming one virtual holistic entity spawning across borders and dedicated to highest research standards. 

A Controlled Environment in clinical trials is achieved through strong collaboration between medical care professionals, the local community, patients and healthcare authorities. ARENSIA Research Clinics have a major vested approach by creating standardized systems and safe harmonized controlled processes across all of our clinics.

During our 10 years of activity in early phase clinical research, we at ARENSIA have achieved to create a highly efficient controlled environment, enabling us to perform most sophisticated Phase I and II protocols with novel compounds at highest quality.

28.02.2020
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