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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

The pharmaceutical companies are eager to obtain maximum information from fewer clinical trials at early stage. This enables quicker "go/no-go" decision for the development strategy of a given compound. The landscape of early clinical development has dramatically changed over the last years. With the target of obtaining first efficacy data in shortest time possible, the amount of Phase I studies in healthy volunteers has decreased, being replaced by Phase Ib/IIa studies in patients.

The need for patients in Phase I and II exploratory trials is posing a great challenge to Sponsors, due to lack research sites able to manage complex exploratory / mechanistic protocols with intensive PK/PD procedures and hospitalization of patients, while delivering reliable and fast enrolment speed.

To help the acceleration of the drug development process and solve the above challenges, ARENSIA has build up its own network of 9 state-of-the-art exploratory medicine units, with full Phase I infrastructure, located across prestigious University Hospitals in Eastern Europe: Romania, Republic of Moldova, Georgia and Ukraine.

WHY IS ARENSIA UNIQUE?

  • ARENSIA is focused entirely on early patient studies - only enrolling healthy volunteers as matching to patients
  • Performance of sophisticated Phase Ib / IIa / POC patient protocols
  • Recruitment at extraordinary speed
  • Own network of modern, dedicated Exploratory Medicine Units with full time medical staff
  • Corporate SOP system followed by all ARENSIA Units
  • Principal Investigators belonging to the medical elite of the respective country
  • Experience with complex study logistics
  • Ability to perform intensive PK/PD schedules with (long) hospitalization
  • Outstanding reputation for safety and quality

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