Clinical Development Department

Clinical Development Department

The Clinical Development Department is comprised of the Pharmacokinetic Studies Team and the Phase Clinical Studies Team. The former conducts early-phase studies focusing mainly on pharmacokinetic assessment and biological equivalence studies of medicinal products. The Phase Clinical Studies Team performs clinical trials for specific therapeutic indications and non-interventional clinical studies.
The Clinical Development Team is responsible for managing and coordinating projects in collaboration with CROs, SMOs, and leading clinical centers in Poland and abroad.
The Pharmacokinetic Studies Team conducts early-phase studies which, in addition to bioequivalence studies, include pharmacokinetic studies. They are an important stage in drug development and may be conducted to determine drug-drug and drug-food interactions, or determine the pharmacokinetic profile in special patient populations. These studies are conducted not only in Poland but also in other European and non-EU countries in compliance with the ICH-GCP principles and applicable regulations.
The main areas of Adamed’s clinical studies include oncology, cardiology, gynecology, urology, and central nervous system disorders. Late-phase clinical studies (phases 2 to 4) are conducted to assess the efficacy and safety of medicinal products in therapeutic areas selected on the basis of the company’s rich clinical development program.
The sites running these studies are subject to regular inspections by drug regulatory agencies (e.g. EMA, FDA, ANVISA), as well as periodical audits by qualified persons from the Clinical Development Department.
The Clinical Development Department is composed of professionals who combine pharmacotherapeutic and clinical expertise with operational and business practice.
Professional coordination of the clinical development process per the pharmaceutical industry’s quality standards (GLP, GCP, GMP), combined with the team’s innovative approach, creativity, and enthusiasm, ensure clinical research of the highest quality is carried out at Adamed Pharma S.A.