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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 safety and efficacy. It is essential to make faster go/no-go decisions on whether to continue their research before any major investments are made to progress drug development to later phases of research.

There are an increasing number of studies that require expert 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 hospitalization. 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, over the last 10 years, ARENSIA has built up its own eight (8) research clinics, with full Phase I infrastructure. ARENSIA´s state-of-the-art clinics are entirely dedicated to perform most sophisticated Phase Ib / IIa / PROOF OF CONCEPT trials, exclusively in patients, across a variety of therapeutic areas. These research clinics are located within confined space in prestigious University Hospitals in Romania, Republic of Moldova, Georgia, and Ukraine, with whom ARENSIA has been building deep relationships. This has allowed ARENSIA to achieve industry leading recruitment rates across numerous diseases, whilst maintaining the highest resulting data quality.

WHY ARENSIA?

  • Dedicated to early patient studies
  • Own network of modern, purpose designed exploratory research clinics
  • Own highly experienced full time staff at each unit (investigators, nurses, project managers etc.)
  • Proven track record in managing sophisticated Phase Ib / IIa / POC patient protocols
  • Outstanding rapid patient recruitment capabilities
  • Bed space to manage any length of required hospitalization
  • Outstanding reputation for safety and quality
  • Very active Quality Assurance team to ensure all units are aligned on Corporate SOP's
  • Expertise to successfully manage the local regulatory process

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

VIDEO INTRO