Phase I studies (for more details please view also Expertise in Clinical Trials 2 and 3 pages):

First in Human, BA/BE studies, PK profiling and PK/PD studies

SYSTEMIC EXPOSURE

ADHESION performance

BLANCHING studies (VASOCONSTRICTOR ASSAYS)

IRRITATION AND SENSITIZATION STUDIES

Phase II studies:

Selected populations with  focus on:

hepatic impairment

renal impairment

oncologic patients

other specialities: dermatology, neurology, psychiatry, cardiology, gastro-enterology, respiratory diseases, endocrinology

Phase III trials:

Phase III trials carried out in key areas:

Oncology

Neurology

Cardiology

Gastro-enterology

Endocrinology

 

Organised in Hospitals and/or medical practices (in case of studies requiring only ambulatory visits) located in Romania, Moldavia and Georgia.

Proof of concept studies:

We directly perform proof of concept studies in our own clinical centre or in the Hospitals with which we cooperate, depending on the requirements.

Trough our partners we can also help you to:

  • reposition molecules
  • find new indications
  • improve the safety profile
  • identify early diagnostic markers and/or identify response to therapy markers

Clinical studies performed for Medical Devices includes:

  • EFFICACY AND SAFETY CLINICAL STUDIES

performed in order to demonstrate the efficacy and the safety of the medical device, according to the specifications. Performed in conformity with ISO-14155-1 and 14155-2.

  • IN VIVO IRRITATION STUDIES

Clinical studies performed in Healthy Volunteers in conformity with ISO 10993-10, ISO-14155-1 and 14155-2.