Clinical Research
While conducting clinical research, ELPEN's Research and Development department operates under strict policies according to the relevant international legal framework and EU Directives and adheres to Standard Operating Procedures (SOPs). Clinical studies are conducted according to the provisions of the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and the Declaration of Helsinki.
Ensuring the safety of patients participating in clinical studies is ELPEN's primary concern. To document and ensure patient safety, all clinical study research proposals are audited internally; during the audit, both published papers and internal company in vivo/in vitro data are taken into consideration.
ELPEN carries out clinical studies across a medicine's Product Life Cycle Management, including interventional and non-interventional Phase I-IV studies.
In the context of interventional clinical studies and after the initial Clinical Trial Protocol is drafted, an application to receive a code number is submitted to the European Clinical Trials Database (EudraCT), according to the regulations set by the European Medicines Agency (EMA). Following this step, each study – now identified by a unique EudraCT code – is submitted for approval to the competent Regulatory Authority (in Greece, the National Organization for Medicines - EOF) and to the National Ethics Committee - NEC (an independent body issuing opinions, assessing proposals and constantly monitoring clinical studies to ensure that patient rights, safety, well-being and dignity are protected at all times). Clinical studies may only start upon written approval issued by the competent Authorities and always pursuant to the National/local and EU legislation.
The clinical studies sponsored by ELPEN are listed in Greek and international databases (FDA: clinical trials.gov, SFEE [Hellenic Association of Pharmaceutical Companies]: "δήλον" database).
Adhering to international regulations and adopting a policy of responsibility and transparency, ELPEN actively supports transparent communication regarding any clinical study-related issue.
Education
Honoring a long-standing commitment to groundbreaking research towards the advancement of science, the Research & Development Department has always welcomed undergraduate and postgraduate (Master's, PhD and post-doctoral) students, providing training in state-of-the-art analysis techniques as well as support in pharmaceutical and translational research projects of common interest.