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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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REGULATORY PROCESS

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

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New Phase I Unit for pediatrics studies, Bucharest, Romania

HOME · NEWS · NEW PHASE I UNIT FOR PEDIATRICS STUDIES, BUCHAREST, ROMANIA

As of August 2015, ARENSIA expands its operations with a new clinical research unit in Bucharest, Romania.

This unit is fully dedicated to exploratory clinical trials Phase 1 and 2 in PEDIATRIC patients (age 0-18) with chronic and acute conditions, such as:

  • Respiratory
  • Immunology (incl. rheumatology & allergies)
  • Eye condition (retinopathy of prematurity)
  • Gastro-enterology
  • Cardiology

The unit is located within the “Institute for Mother and Child Care” (IMCC), with whom ARENSIA has closed a strategic partnership in the field of exploratory clinical research. The Institute for Mother and Child Care was founded more than 50 years ago and is a public medical institution with a rich medical history, being entirely dedicated to medical research and treatment of pediatric patients.

IMCC is equipped state-of-the art, incl. on-site clinical lab facilities and imaging technologies. It has 205 in-patient beds, spread across 4 buildings: in rheumatology, cardiology, gastroenterology, respiratory infections, and intensive therapy for new born, plus a large ambulatory clinic with following specialties: ophthalmology (RET-cam), genetics, nose-throat-ear, neuropsychiatry & psychology, dentistry, endocrinology, orthopedic surgery, dermatology, immunology & allergies.

IMCC is also university clinic for the leading medical school in Bucharest, “Carol Davila” University of Medicine and Pharmacy.

IMCC employs 26 MD pediatricians. The medical staff at IMCC is trained at highest standards. The key leading physicians have broad experience in late phase clinical research for the international pharmaceutical industry.

Diagnosis and treatment of pediatric patients in Romania follow national guidelines, which are updated annually following EAP (European Academy of Pediatric) guidelines.

Due to its specialization and reputation, IMCC is the leading reference center for entire Bucharest metropolitan area (2,5 Mio. inhabitants).

Yearly approximately 35,000 pediatric patients are admitted for ambulatory day care and 7,500 are hospitalized in IMCC. Patient files are well documented and centralized. Various national patient registries (e.g. cystic fibrosis, prematurity retinopathy cardiology excellence center, regional immunodeficiency center ) are managed by IMCC.

ARENSIA performs its activities in a dedicated ward with 8 beds for intensive monitoring (24 hrs surveillance). ARENSIA has access to all areas of expertise in IMCC.

Following type of clinical research projects can be performed by ARENSIA in this unit:

  • Single Ascending Dose (SAD)/ Multiple Ascending Dose (MAD)
  • Bioequivalence (BE)
  • Vaccine studies

We have the ability to perform protocols with intensive PK/PD sampling, as well as with long confinement.

The ICU is in the same building ( at 4th floor ) as ARENSIA clinical pharmacology wards. Immediate emergency care is provided by the ICU teams 24 hrs per day, 7 days per week. Safety is our number one priority and we ensure that all necessary systems are in place to achieve this.

Adjacent to ARENSIA´s Phase 1 unit, a 20 beds isolator track can be used for trials where patients with infectious condition shall stay isolated.

ARENSIA´s core specialist team in this Phase 1 unit consists of 4 MD investigators (pediatricians, specialized in emergency care) and 2 study nurses, supported operationally by the entire ARENSIA Phase 1 infrastructure in Bucharest, Romania.

The research partnership between ARENSIA and IMCC aims to:

  • offer pediatric patients in Romania access to new/improved therapies as early as possible, and
  • enable pharmaceutical industry uniquely fast recruitment rates within a high-quality Phase 1 environment dedicated to the performance of early clinical trials in pediatric patients.

Other pediatric populations (e.g. infectious diseases hepatitis, HIV) can be offered at other ARENSIA sites.

10.11.2015