SMART PROOF OF CONCEPT

Our Sponsors search to obtain as much as possible 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. We have witnessed that 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 scientifically complex (biomarker) first into patient trials
  •  hospital-based, modern, clinical pharmacology units in Eastern Europe which guarantees fast patient recruitment
  •  a highly competitive regulatory environment

which is a great opportunity for Pharmaceutical 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 creative regulatory strategy. This can be achieved by planning an exploratory package (“one umbrella” protocol) and coordinating the activities for FIM studies (in healthy volunteers)  - typically performed by CROs in Western Europe or US - with early patient studies at ARENSIA performed in Eastern Europe.

Based on a concrete study concept we are glad to share the details of such a strategy with our Sponsors (incl. the related estimated budget and timelines).

Contact

ARENSIA Exploratory Medicine GmbH

Merowingerplatz 1
40225 Duesseldorf, Germany

Email: undefinedinfo(at)arensia-em.com

Office phone: +49 (211) 15 77 89 0
Office fax:      +49 (211) 15 77 89 10

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