Clinical Development Department

Clinical Development Department

The Clinical Development Department is comprised of the Bioequivalence Studies Team and the Phase Clinical Studies Team. The first one conducts early-phase studies focusing mainly on pharmacokinetic assessment and biological equivalence studies of medicinal products. The Phase Clinical Studies conducts clinical trials for a particular therapeutic indication and non-interventional clinical studies.

The Clinical Development Team is responsible for managing and coordinating projects in collaboration with CROs, SMOs, and leading clinical centres in Poland and abroad.

The Bioequivalence Studies Team conducts more than 20 early-phase studies a year which, apart from bioequivalence studies, also include pharmacokinetic studies. These studies are an important stage in the development of an innovative drug and may be conducted to determine drug-drug and drug-food interactions, or define the pharmacokinetic profile in special patient populations. They are conducted not only in Poland but also in other European and non-EU countries in compliance with the ICH-GCPprinciples and applicable regulations.

The main areas of Adamed’s clinical studies include oncology, cardiology, gynaecology, 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 chosen based on the company’s rich clinical development programme.

The centres conducting these studies are subject to regular inspections by regulatory agencies (e.g. EMA, FDA, ANVISA), as well as periodical audits by qualified staff 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.