Clinical Investigation (CI), with a focus on applied clinical research, clinical pharmacology and therapeutics. The cluster empowers the execution of high quality clinical research operations spanning all phases of drug development, having also as a major priority to include in the near future clinical investigation associated with biosimilar and generic drugs including clinical trial for drugs targeting niche and/or high-growth markets such as oncology.
Bionian Cluster has the ability to manage the procedures concerning the application for marketing authorization for generics and prototype drugs in the Central and Western Europe. Additionally, we offer practical conduct of all phases of clinical studies (the I-II-III-etc.), bioequivalence studies, environmental residues and veterinary drugs (marketing authorization is included).
The Institute for Clinical Investigation (ICI), a valuable member of Bionian Cluster, acts as a Contract Research Organization (CRO) on behalf of the Biopharma Industry, Academic Centers, Investigators and other Public or Private Bodies and offers pre-clinical research, management of clinical trials of all phases (I-IV), as well as all the categories of investigation of medical devices. It has established collaborations with globally renowned Universities, Research Institutes, state Institutions and Hospitals, a fact that enhances its presence on the international environment of CRO-companies. ICI, modeled according to the General Clinical Research Centers in the USA and Europe, operates strictly according to the ICH- GCPs and the current legislation, regulations and guidelines οf the International and National organizations (FDA, MHRA, EMA, EOF). The multidisciplinary and highly skilled personnel of I.C.I. has been endowed with an extensive range of academic titles and qualifications, as well as a broad experience in bioequivalence, pre-clinical and clinical research.