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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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INNOVATION AND EFFICIENCY IN EARLY CLINICAL TRIALS

Pharmaceutical and Biotechnology companies are under increased pressure to advance compounds whilst ensuring high efficacy and safety.  They are under pressure to make faster go/no-go decisions on whether to continue their research before any major investments are made to advance drug development to later phases of research.

There are an increasing number of studies that require; research sites dedicated to Phase I/II patient studies with the ability to manage complex protocols with intensive PK/PD procedures, patient assessments, and considerations around hospitalisation.  The increasing demands present the most difficult challenges for pharmaceutical and biotechnology companies in gaining reliable quality data in the shortest possible period.

To alleviate the challenges and to support the acceleration of drug development, ARENSIA has its own network of nine (9) state of the art exploratory medicine units with full Phase I / II / PROOF OF CONCEPT patient capabilities.  These modern units are located within dedicated areas in prestigious University Hospitals in Romania, Republic of Moldova, Georgia, and Ukraine.  

ARENSIA has been building deep relationships with each of the hospitals where our units reside.  This has allowed ARENSIA to achieve industry leading recruitment rates across a number of therapeutic areas, whilst still maintaining the highest resulting data quality.

WHY IS ARENSIA UNIQUE?

  • Dedicated to patient studies
  • Own network of modern, purpose designed, exploratory medicine units with diagnostic and laboratory equipment
  • Clinical research experienced therapeutic specialist principal investigators, research nurses, medical technicians, pharmacists and project coordinators at each unit
  • Highly experienced research oriented project managers
  • Proven track record in managing sophisticated Phase Ib / IIa / POC patient protocols
  • Outstanding rapid patient recruitment capabilities
  • Vast understanding of complex study logistics
  • Strong capabilities and expertise to perform intensive PK/PD assessments
  • Bed space to manage any length of required hospitalization
  • Significant positive reputation for safety and quality
  • Controlled research dedicated secure on site pharmacies for drug preparation and storage
  • Dedicated space for patient sample management at each unit
  • Very active Quality Assurance team to ensure all units are aligned on Corporate SOP's

Working with ARENSIA leads to increased efficiency by shortening recruitment time while the number of involved sites/countries can be reduced. This translates into considerable cost savings for the SPONSOR at overall project level.

LATEST RECRUITMENT PERFORMANCE

Recruitment rates in completed multicenter trials: ARENSIA vs. COMPETITOR AVERAGE