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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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Successful EMA Inspection at ARENSIA EXPLORATORY MEDICINE, Moldova

HOME · NEWS · SUCCESSFUL EMA INSPECTION AT ARENSIA EXPLORATORY MEDICINE, MOLDOVA

ARENSIA EXPLORATORY MEDICINE GmbH, a German based clinical research organization specialized to perform Phase Ib/IIa/PROOF OF CONCEPT clinical trials involving patients, announced today, that its Phase I clinical research unit in Chisinau, Moldova has successfully completed a clinical trial joined local and European Medicines Agency (EMA) inspection.

The two-day trial joined-inspection by two EMA and two inspectors of local Medicines and Medical Devices Agency of the Republic of Moldova was undertaken at ARENSIA´s Phase I unit in Chisinau, Moldova on 16-17 of June, 2018.

The inspection was performed to check the compliance with Good Clinical Practice (GCP) for a Phase I clinical trial in the area of hepatology where 48 Hepatitis C patients have been enrolled by ARENSIA´s Phase I unit in Chisinau in 28 weeks.

The inspection concluded that the clinical trial was conducted in accordance with GCP and national legislation; no critical or major observations were raised during the inspection. The final Clinical Trials Inspection Report was released on 4th of December, 2018.

“The positive outcome of this inspection confirms the efficient teamwork and commitment to quality by each of our colleagues working across the entire company. We are proud of our contribution to develop new medicines faster, and devotion to patients´ medical prosperity” said Dr. Claudia Hesselmann, ARENSIA´s Co-founder and Managing Director. "A big THANK YOU to all ARENSIA teams involved in this complex project for their dedication and hard work!”

“This successful inspection is a proof of an impeccable planning done at all levels of clinical trial activities, combined with excellence in delivery by all team members. Three qualities are characterizing each and every ARENSIA´s team member, being key for this outstanding result: dedication, motivation and responsibility - under the umbrella of professionalism,” commented Dr. med. Neli Ghicavii, Country Manager of ARENSIA Exploratory Medicine in Chisinau, Moldova. "Patients’ safety and quality of data are of paramount importance at ARENSIA. Thriving to deliver operational excellence in exploratory clinical trials is the fuel for all our daily activities that are done with true passion for developing novel drugs and true compassion for our patients.”

The Chisinau Phase I Unit, opened in January 2011 is one of ARENSIA’s eight sites to offer performance of complex Phase Ib/IIA and Proof of Concept Trials involving patients, across numerous therapeutic areas.

The following types of trials are performed in ARENSIA Exploratory Medicine Units:

• First-in-Patients SAD/MAD adaptive design: safety, efficacy, dose finding
• Integrated/Umbrella/Basket/Platform protocols
• PROOF OF CONCEPT
• Bioavailability/Bioequivalence
• Biosimilars
• Drug-Drug-Interaction
• QT/Thorough QT
• Phase I PK in Renal & Hepatic Impairment (all stages) vs. matching healthy volunteers

ARENSIA EXPLORATORY MEDICINE GmbH (www.arensia-em.com) is a German clinical research organization specialized to address the need for FAST PATIENT RECRUITMENT in Phase I / II / PROOF OF CONCEPT clinical trials. ARENSIA has built up its own network of state-of-the-art Exploratory Medicine Units, with full Phase I infrastructure, located across prestigious University Hospitals in Eastern Europe – Romania, Moldova, Georgia, and Ukraine. ARENSIA units are dedicated to conduct sophisticated exploratory protocols with novel compounds that require intensive PK and PD assessments, with or without long hospitalization.

04.12.2018