Proof of Concept

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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SMART PROOF OF CONCEPT

The pharmaceutical companies search to obtain maximum of information from fewer clinical trials at early stage, in order to decide the “go/no-go” for the development strategy of a given compound as early as possible within the development plan.

Over the last years, the exploratory clinical trials - be it in healthy volunteers, but especially in patients - became more and more complex in terms of design and end points, and with an increased number of subjects.

ARENSIA offers the combination of:

  • an experienced team able to reliably perform sophisticated First-into-Patient trials
  • hospital-based, modern Exploratory Medicine Units in Eastern Europe with fast patient recruitment
  • a competitive regulatory environment

which is a great opportunity for Sponsor companies to considerably reduce time and resources, enabling acceleration to PROOF OF CONCEPT.

ARENSIA can additionally save time towards PROOF OF CONCEPT by using a compact regulatory strategy. This can be achieved with “integrated” protocols, coordinating the activities for First-in Man studies in healthy volunteers  – typically performed by CROs in Western Europe or US – with First-in-Patient studies performed at ARENSIA units in Eastern Europe.

ARENSIA has successfully contributed to numerous “integrated” protocols in immunology, dermatology, gastroenterology and infectious diseases, for both large pharmaceutical companies and small biotechnology companies.

Based on a concrete study concept we are glad to share our expertise of such a strategy, incl. the related estimated budget and timelines.