WE.SPEED.
Pharmaceutical and Biotechnology companies are increasingly required to gather concise knowledge of the characteristics of a given compound with fewer clinical trials at a much early stage. This is to reduce the time taken to decide on the continuation of the development strategy. This is fundamental for both scientific and economic justifications.
Every year exploratory clinical trials become more and more complex. There is an increased level of design complexity and endpoints with larger sample sizes.
Examples from the recent past show that when involving ARENSIA, Sponsors achieve a time reduction by ca. 60% through unrivaled recruiting performance and an overall budget reduction by 70% for a Phase IB/IIA patient trial by concentrating effort on a few ARENSIA Clinics vs. high number of typical clinical trials sites.
On top of these benefits, ARENSIA offers industry-leading results in Safety and Quality, including successful audits by FDA and EMA, 13 years of experience in various, complex study designs in a multitude of indications.
ARENSIA can further reduce the time to PROOF OF CONCEPT by executing a compact regulatory strategy. This is achieved with “integrated” type of protocols. Specifically, by coordinating the activities for First-in-Man studies in healthy volunteers - typically performed by CROs in Western Europe or the US - with First-in-Patient studies performed at ARENSIA´s research clinics.
ARENSIA has successfully contributed to numerous “integrated” protocols in immunology, dermatology, gastroenterology, and infectious diseases, for both large pharmaceutical companies and small biotechnology companies.